BioScience Today 16 by Distinctive Media Group Ltd

SCIENCETODAY

BIO

SPRING2019

have clinical trIAls failed older people ?

training for future generations News • Aerospace and Medicine • Autism and ADHD • Intellectual Property • Ageing and Clinical Trials • Training and Education

palladium catalysts niobium

erbium fluoride sputtering targets 3

zeolites 11

anode

2 1

2 8 1

osmium

Mg 24.305

Sodium

Magnesium 2 8 8 1

2 8 18 8 1

MOFs ZnS

Rb Cs

AuNPs

2 8 18 18 8 1

Francium

2 8 18 9 2

Ra (226)

Ac (227)

Radium

50.9415

Vanadium

91.224

2 8 18 18 9 2

138.90547

2 8 18 10 2

104

Rf (267)

2 8 18 12 1

2 8 18 32 10 2

Db (268)

Rutherfordium

2 8 18 13 1

51.9961

EuFOD

Ce 140.116

quantum dots

Th 232.03806

2 8 18 21 8 2

140.90765

Cerium 90

Mo 95.96

2 8 18 32 11 2

Praseodymium 2 8 18 32 18 10 2

Thorium

Pa 231.03588

2 8 18 32 20 9 2

2 8 18 32 32 11 2

2 8 18 32 12 2

238.02891

Protactinium

Uranium

2 8 14 2

2 8 18 15 1

106

Sg (271)

2 8 18 22 8 2

2 8 15 2

2 8 18 16 1

Tc Re

2 8 18 32 32 12 2

107

Bh (272)

2 8 18 23 8 2

2 8 16 2

2 8 18 18

Pm Sm (145)

Np (237)

Neptunium

Ru 101.07

2 8 18 32 13 2

108

(270)

2 8 18 1

2 8 18 18 1

106.42

2 8 18 32 15 2

192.217

2 8 18 32 32 14 2

109

Mt (276)

195.084

Meitnerium

110

Ds (281)

111

2 8 18 25 8 2

151.964

2 8 18 32 24 8 2

2 8 18 25 9 2

157.25

Europium

(280)

Roentgenium

2 8 18 27 8 2

158.92535

Gadolinium 2 8 18 32 25 8 2

112

(285)

2 8 18 32 27 8 2

(244)

(243)

Americium

(247)

Curium

(247)

(251)

Berkelium

Californium

rhodium sponge

(252)

Einsteinium

2 8 18 18 3

2 8 18 32 32 18 2

2 8 18 29 8 2

2 8 18 18 4

113

Nh (284)

Fl (289)

Nihonium

Flerovium

Mc (288)

2 8 18 32 18 5

Moscovium

Lv (293)

2 8 18 32 18 6

OLED lighting

laser crystals

117

2 8 18 32 32 18 6

Ts (294)

2 8 18 30 8 2

167.259

100

(257)

Fermium

2 8 18 31 8 2

168.93421

173.054

Thulium

2 8 18 32 30 8 2

101

Md (258)

2 8 18 32 8 2

2 8 18 32 31 8 2

102

No (259)

Mendelevium

2 8 18 32 32 8 2

Nobelium

2 8 18 32 18 8

(222)

Radon 2 8 18 32 32 18 7

103

118

Og (294)

2 8 18 32 32 18 8

h-BN

yttrium

Oganesson

Lr (262)

calcium wires

mischmetal

Lawrencium

chalcogenides

CVD precursors deposition slugs YBCO

photovoltaics

metamate

supercond

solar energy

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spintronic

platinum ink

optical glass

Inva

GDC

2 8 18 32 32 8 3

rare earth metals

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dielectrics

cermet

2 8 18 18 8

131.293

174.9668

Ytterbium

ium niobate

etics

2 8 18 8

83.798

2 8 18 32 9 2

state-of-the-art Research Center. Printable GHS-compliant Safety Data Sheets. Thousands of

MOCVD

Nd:YAG

silver nanoparticles

Over 15,000 certified high purity laboratory chemicals, metals, & advanced materials and a

ferrofluid

2 8 18 32 18 7

2 8 8

Krypton

Tennessine

scandium powder

ultra high purity materials

(210)

ium pellets

lanthanum rods

2 8 18 18 7

Astatine

Livermorium

Now Invent.

sputtering targets

Iodine

mesoporous silica

2 8 18 7

126.90447

(209)

116

39.948

Argon

79.904

Polonium 2 8 18 32 32 18 5

Bromine

127.6

208.9804

115

2 8 18 18 6

Tellurium

Bismuth 2 8 18 32 32 18 4

78.96

Neon

35.453

2 8 18 6

ITO

20.1797

2 8 7

Chlorine

Selenium

121.76

2 8 18 32 18 4

2 8 6

Antimony

207.2

114

2 8 18 18 5

74.9216

Lead 2 8 18 32 32 18 3

2 8

nano ribbon

Fluorine

32.065

2 8 18 5

18.9984032

Sulfur

Arsenic

Tin

2 8 18 32 18 3

30.973762

2 8 18 4

15.9994

2 8 5

He Helium

2 7

CIGS

4.002602

2 6

Oxygen

Phosphorus

72.64

Erbium 2 8 18 32 29 8 2

118.71

Holmium 2 8 18 32 28 8 2

204.3833

164.93032

Dysprosium

2 8 18 3

Thallium

Copernicium

162.5

Terbium

2 8 18 32 25 9 2

2 8 18 28 8 2

28.0855

114.818

2 8 18 32 18 2

2 8 4

Indium

Pu Amstabilized Cm Bk zirconia Cf Es Fm yttrium Plutonium

14.0067

Germanium

macromolecules

2 8 18 24 8 2

2 5

Nitrogen

Silicon

69.723

200.59

2 8 18 32 32 18 1

Gallium

Mercury

cerium oxide polishing powder

tungsten carbide

Gold

Darmstadtium

2 8 18 18 2

112.411

196.966569

2 8 18 32 32 17 1

Cadmium 2 8 18 32 18 1

2 8 3

Zinc

Silver

2 8 18 32 17 1

2 8 18 2

65.38

107.8682

Platinum 2 8 18 32 32 15 2

Copper

Palladium

Iridium

Hassium

150.36

102.9055

2 8 18 32 14 2

12.0107

26.9815386

63.546

Nickel

Rhodium

190.23

Samarium

2 8 18 32 22 9 2

Osmium 2 8 18 32 32 13 2

58.6934

Cobalt

Ruthenium

Bohrium

58.933195

Iron

186.207

Promethium 2 8 18 32 21 9 2

55.845

Rhenium

Seaborgium

144.242

(98.0)

183.84

Neodymium

transparent ceramics

efractory metals

2 8 18 13 2

Technetium

Tungsten

Dubnium

54.938045

anti-ballistic ceramics 2 8 18 19 9 2

2 8 13 2

Manganese

Molybdenum

180.9488

105

Chromium

Tantalum 2 8 18 32 32 10 2

2 8 13 1

2 4

Carbon

Aluminum

ultralight aerospace alloys

92.90638

178.48

2 8 18 32 18 9 2

2 8 11 2

Niobium

Hafnium

Actinium

MBE

Zirconium

Lanthanum 2 8 18 32 18 8 2

47.867

Yttrium

2 8 18 18 8 2

2 8 10 2

Titanium

88.90585

137.327

2 8 18 32 18 8 1

44.955912

Barium

2 8 9 2

Scandium

87.62

Cesium

(223)

2 8 18 8 2

Strontium

132.9054

40.078

85.4678

2 8 8 2

Calcium

Rubidium

10.811

electrochemistry

nanodispersions

2 3

Boron

2 8 2

isotopes

39.0983

Potassium

silicon rods

copper nanoparticles

9.012182

Beryllium

22.98976928

2 2

99.999% ruthenium spheres

6.941

Lithium

organometallics

1.00794

Hydrogen

diamond micropowder

III-IV semiconductors

additive manufacturing

buckyballs

glassy carbon

europium phosphors alternative energy

nickel foam

thin film

Now Invent!

metallocenes

li-ion battery electrolytes

InAs

Ti-6Al-4V

ÂŠ 2001-2019. American Elements is a U.S.Registered Trademark

www.biosciencetoday.co.uk

| BIOSCIENCE TODAY |

| welcome |

Welcome 2019: A Space Odyssey Ellen Rossiter Editor in chief

Editor Ellen Rossiter ellen.rossiter@distinctivepublishing.co.uk

Design Distinctive Publishing, 3rd Floor, Tru Knit House, 9-11 Carliol Square, Newcastle, NE1 6UF Tel: 0191 580 5990 www.distinctivepublishing.co.uk

Advertising Distinctive Publishing, 3rd Floor, Tru Knit House, 9-11 Carliol Square, Newcastle, NE1 6UF Tel: 0191 5805990 e: ewan.waterhouse@distinctivegroup.co.uk www.distinctivepublishing.co.uk

You may detect a sprinkle of stardust in our latest issue. Here’s your starter for ten. What do smoke alarms, Cubic Zirconia and CT scans have in common? They all owe their development to the space race. Breakthroughs in technology, health care (and yes, jewellery) have all been attributed to advances in the space race. Far from being the final frontier, space-related technology has repeatedly proven the genesis for advances from imaging techniques to using light-emitting diodes for cancer treatment. We take a look at the search to find the next generation of life changing health care solutions. The UK Space Agency and NHS England are judging applications for funding which will see space technology utilised to tackle challenges facing the NHS, from early cancer diagnosis to managing long term conditions. We await the results with interest. We’re also given an insight into the work of The Institute of Aerospace Medicine at the German Aerospace Center (DLR), where biomedical and psychological research in space is applied on earth. Putting people’s needs at the centre of our research and health care delivery is imperative – and it’s at the heart of several articles in this issue. Giving us food for thought about how research priorities are chosen and how we ensure clinical trials are inclusive and representative.

Distinctive Publishing or BioScience Today cannot be held responsible for any inaccuracies that may occur, individual products or services advertised or late entries. No part of this publication may be reproduced or scanned without prior written permission of the publishers and BioScience Today.

In a different spin on technological advancements, we reflect on how social media has given patients and health care providers another means to communicate and acted as an equaliser in information provision. Patients are coming together to share their experiences and needs on social media, thereby informing the focus of future research. We also hear how a new tool is comparing disease prevalence to research activity in a specific specialty or condition and thereby

helping to target clinical trials to areas of unmet clinical need. In Newcastle, a sea change is being brought about in how clinical trials are designed and carried out in order to reflect the priorities of older people and facilitate their involvement. We learn how making it easier for older people to take part in and stay in clinical trials will generate better research outcomes. Whilst in London, researchers are embarking on a three-year study which aims to identify infants at a higher than average risk of autism spectrum conditions (ASC) and attention deficit hyperactivity disorder (ADHD). In the hope, their findings will enable support to be made available earlier for those affected. Could vaccinations be an underused tool in the provision of infection control for people of all ages? Last year marked a century since the outbreak of Spanish Flu, but lessons remain to be learnt from this pandemic. Find out how vaccinations are a key component of healthy ageing. You may be surprised to learn that blood cancers are the third biggest cancer killer in the UK – claiming 15,000 lives each year, more than breast cancer or prostate cancer. Over 40,000 people of all ages are diagnosed with blood cancers, which include leukaemia, lymphoma and myeloma, every year in the UK, so we felt it was important to find out about advances in treatment. Though significant progress has been made, work remains to be done to ensure these improvements benefit as many people as possible and further improvements are made, making continued investment vital. The skills gap is something about which we hear frequently, so we were interested to learn how degree apprenticeships could help bridge the gap and provide a talent pipeline. Fasten your seat belts, as this issue is ready for lift-off…

| contents |

features

| BIOSCIENCE TODAY |

Making clinical trials right for older people

18 Out of this world. The UK Space Agency and NHS England are currently judging ideas for how technology originally designed for space could help solve major health and care challenges facing the NHS. Research at the interface of technology and life sciences

| BIOSCIENCE TODAY |

| contents |

contents www.biosciencetoday.co.uk / issue 16 /spring 2019

Introduction/Foreword

4-5

Contents

6-7 Biodigestables 8

Industry Contributors

9-17 News

18-22

26-28

30-35

36-41

42-43 44-45

46-53

The benefits of government apprenticeship reforms to employers

Aerospace and Medicine

The UK Space Agency and NHS England are currently judging ideas for how technology originally designed for space could help solve major health and care challenges facing the NHS. Research at the interface of technology and life sciences

Autism and ADHD

The baby brain scans that could help predict symptoms of autism and ADHD

Intellectual Property

Considering a pharma and bioscience patent? The UK Intellectual Property Office maps out the application journey

Ageing and Clinical Trials

Making clinical trials right for older people Bringing patients and providers together one tweet at a time Adult Vaccination – an undervalued tool for infection prevention

Finance and Funding

Investment at the beating heart

Future Growth

An insight into the Cambridge economy – what lies ahead for Silicon Fen?

Training and Education

The benefits of government apprenticeship reforms to employers ‘Snobbery’ is depriving people of a great career Degree apprenticeships: a first class route to building a talent pipeline

| biodigestables |

| BIOSCIENCE TODAY |

BIODIGESTABLES

£10m government investment

UK HIV diagnoses continue to fall

Biotechnology manufacturing centre

A network of northern universities, hospitals and medical technology companies, including the University of Sheffield, has been awarded a £10.1 million investment from UK Research and Innovation to expand a digital pathology and artificial intelligence programme.

A new report published by Public Health England (PHE) showed that the UK is one of the first countries to meet the UNAIDS 90-90-90 targets, highlighting that prevention efforts are working in the UK. New estimates revealed that in 2017, 92% of people living with HIV in the UK have been diagnosed, 98% of those diagnosed were on treatment, and 97% of those on treatment were virally suppressed.

GE Healthcare has announced the opening of a biotechnology manufacturing centre in Stevenage, UK. In the first half of 2019, the centre will start producing a fiber-based purification platform, which has the potential to significantly improve efficiency in the purification steps of manufacturing biopharmaceuticals, gene therapies and viral vectors.

Greg Clark, Secretary of State for Business, Energy and Industrial Strategy (BEIS), announced the investment, as part of the Industrial Strategy Challenge Fund.

Female heart patients missing out

Cutting-Edge Facility Birmingham to lead ground-breaking research Nearing Completion

BHF calls for an urgent overhaul of how women are receiving cardiac rehabilitation~

Birmingham health researchers, with industry partners including health technology companies Dignio and Datatrial, have been awarded £1.1 million by UK Research & Innovation (UKRI)’s Innovate UK, to investigate patients’ experience of cell and gene therapies. The funding has been provided as part of the Industrial Strategy Challenge Fund’s Medicines Manufacturing programme.

Thousands of female heart patients could be at higher risk of dying every year due to poor uptake of cardiac rehabilitation, according to new figures released by the British Heart Foundation. An analysis of figures in the charity’s National Audit of Cardiac Rehabilitation (NACR) report, has revealed that in England only 43% of women eligible for cardiac rehab take it up, compared to 53% of men.

Cell and gene therapies offer ground-breaking opportunities for the treatment of disease and injury. As therapies of this kind are so new, the impact upon patients receiving them has not yet been studied – until now.

Construction work on CPI’s new, state-of-the-art, healthcare photonics facility is being finalised. The centre, based at NETPark in Sedgefield, County Durham, will help develop next-generation lightbased treatments for the healthcare industry. The cutting-edge facility will support the scale-up and commercialisation of medical technology (medtech) products, acting as a hub for businesses of all sizes and academic partners. The photonics centre will enable work on innovative methods of diagnosing disease, imaging systems - including endoscopy - and light-based treatments

Heart models could improve cardiac care

Absolute Antibody expands

Genomes Project reaches goal

Ground-breaking computer models that simulate the workings of individual patients’ hearts could boost treatment of a common cardiac condition that affects a million people in the UK and countless more worldwide.

Antibody specialist Absolute Antibody Ltd has announced a major new expansion to its site in North East England. The company opened a production facility in the area just two years after it was founded in Oxford in 2012, and has undergone rapid expansion since then. It now provides custom antibody sequencing, engineering and expression services to leading pharmaceutical, biotechnology and diagnostics companies, as well as academic researchers worldwide.

The 100,000 Genomes Project has reached its goal of sequencing 100,000 whole genomes from NHS patients. Established with the support of the MRC, the project began in 2012 to uncover new diagnoses and improved treatments for patients with rare diseases and cancer.

With funding from the Engineering and Physical Sciences Research Council (EPSRC) and in collaboration with St Thomas’ Hospital, a team at King’s College London has taken the first steps in developing models designed to optimise a procedure that corrects atrial fibrillation, a condition which causes abnormal heart rhythms.

One in four participants with rare diseases has received a diagnosis for the first time, and up to half of cancer patients involved have been provided with findings which may allow them the opportunity to take part in a clinical trial or to receive a targeted therapy.

| BIOSCIENCE TODAY |

| biodigestables |

BIODIGESTABLES

Give patients an active role

Whale songs’ changing pitch

How yoga benefits older people

Patients need to be given opportunities to educate doctors about their experiences of living with their conditions to improve patient centred care, a recent study conducted in Leicester suggests.

Blue whales around the world have been dropping pitch incrementally over several decades, but the cause has remained a mystery. A new international study may have uncovered some clues.

A major £1.4 million study investigating the benefits that yoga brings to older people with multiple long-term health conditions is about to begin at Northumbria University, Newcastle.

A research team, led by Dr Veena Patel, a rheumatology consultant at Leicester’s Hospitals, investigated the views held by UK doctors at the specialist trainee grade on patient centred care (PCC). They found that while many doctors could identify the key components of PCC, there was not uniform understanding across all interviewees.

The study was led by Dr Emmanuelle Leroy, who conducted the research with colleagues at University of Brest & French National Centre for Scientific Research (CNRS), Geosciences Ocean Lab, Plouzané, France. Dr Leroy is now based at UNSW Sydney.

The four-year study is funded by the National Institute of Health Research (NIHR) and follows evidence that people with a number of long-term health conditions are more likely to have reduced physical function, lower quality of life and life expectancy, combined with more need for support with mental health issues.

How cells move

‘Chemputer’

Treatment hope

A new computational model clarifies the structure and mechanics of soft, shape-changing cells, potentially giving scientists a better understanding of cancerous tumour growth, wound healing, and embryonic development.

A radical new method of producing drug molecules, which uses downloadable blueprints to easily and reliably synthesise organic chemicals via a programmable ‘chemputer’, could be set to democratise the pharmaceutical industry, scientists say.

A drug treatment, already approved for use in patients, could offer new hope for some patients with brain bleeding and strokes.

‘Mini-placentas’ Researchers say that new ‘mini-placentas’ – a cellular model of the early stages of the placenta – could provide a window into early pregnancy and help transform our understanding of reproductive disorders. Details of this new research have been published in the journal Nature. Many pregnancies fail because the embryo does not implant correctly into the lining of the womb (uterus) and fails to form a placental attachment to the mother. Yet, because of the complexities of studying this early period of our development, very little is understood about what is happening normally and what can go wrong. Animals are too dissimilar to humans to provide a good model of placental development and implantation.

In a new paper published online in the journal Science, researchers from the University of Glasgow have presented for the first time how synthesis of important drug molecules can be achieved in an affordable and modular chemicalrobot system they call a chemputer.

Diagnostic tool tested A diagnostic tool, which can be used by mental health clinicians to assess children and teenagers, is to be evaluated by experts from the University of Nottingham and Institute of Mental Health, thanks to a £1.5m NIHR grant. The STADIA study (STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties) will test the clinical and cost effectiveness of a standardised diagnostic assessment tool, as an addition to usual clinical care, on the diagnosis of emotional disorders in children and adolescents who are referred to Child and Adolescent Mental Health Services (CAMHS).

New research, led by the University of Glasgow and published in Human Molecular Genetics, has shown that the compound sodium phenyl butyric acid could be used to reduce brain bleeding which can cause strokes when it is caused by a defect in a gene called collagen IV.

Short story or article to share? Send them to our Editor, Ellen Rossiter, at ellen.rossiter@distinctivepublishing.co.uk

BIO

SCIENCETODAY

Led by Corey O’Hern, a Yale professor of mechanical engineering and materials science, physics, and applied physics, the researchers developed an efficient computational model that allows simulated particles to realistically change shape during interactions with other particles. Their results are published Dec. 11 in the journal Physical Review Letters.

The team found a correlation between the seasonal variation in the whale’s pitch with breaking sea ice in the southern Indian Ocean.

| industry contributors |

Professor Jens Jordan Director of the Institute of Aerospace Medicine Professor Jens Jordan took the position as director of the Institute of Aerospace Medicine coupled with the chair of aerospace medicine at University of Cologne in December 2016. Before moving to Cologne, he established an academic clinical research center at the Charité in Berlin and was director of the Institute of Clinical Pharmacology at Hannover Medical School in Germany. He received his training as internist and clinical pharmacologist at the Medical Faculty of the Charité in Berlin and at Vanderbilt University in Nashville.

Miles Witham Professor of Trials for Older People at Newcastle University.

| BIOSCIENCE TODAY |

Tegan Gaetano, MS Public Relations and Advocacy Director, International Foundation for Gastrointestinal Disorders (IFFGD) In her role as Public Relations and Advocacy Director, Tegan has worked to further IFFGD’s education and advocacy priorities, developing and implementing programs designed to enhance the visibility of the foundation and bolster awareness on behalf of the millions of people around the world living with a chronic gastrointestinal illness.

Christopher Burnett Associate Patent Attorney, AA Thornton

Miles is based in the NIHR Newcastle Biomedical Research Centre, where his work focusses on translating results of discovery science into early and late phase trials to improve physical function and quality of life for older people with sarcopenia, frailty and other long-term conditions.

Christopher is a Chartered and European attorney with over fifteen years of experience, and is based in the Chemistry, Biotechnology and Pharmaceuticals team of AA Thornton. Christopher has particular expertise in patenting oilfield technology as well as pharmaceuticals, and also advises on chemical engineering and medical device matters.

Dr Clare Jonas Research Communications Officer at Bloodwise

Robyn Haigh UK Space Agency

After working as a researcher and lecturer in psychology, Clare decided to become a science communicator in 2017. Since then, she’s been helping Bloodwise make sure that the science they fund is accessible to everyone, not just experts.

Robyn is the communications apprentice at the UK Space Agency and is also a marketing volunteer for UKSEDS, the UK’s national student space society. During her time at the Agency she has worked on campaigns such as ‘WISE’, encouraging young women into the space sector and promoting apprenticeships.

Keith Smith Director of Apprenticeships, Education and Skills Funding Agency Keith Smith has worked in the skills system for more than 20 years. He has run local skills programmes, ranging from local jobclubs to assessing apprentices. In recent years he has been leading the development and delivery of the national further education and apprenticeship funding systems. Keith has been a governor of a number schools and university technology colleges.

Dr Laura Starrs Examining Group Head at the UK Intellectual Property Office (IPO) Dr Cullen’s team searches, examines and grants patents in biotechnology and biopharma fields, while Dr Starrs’ team covers organic chemistry and pharma. Both contribute to policy and practice development in these technical fields.

Dr Lawrence Cullen Deputy Director at the UK Intellectual Property Office (IPO) Dr Cullen’s team searches, examines and grants patents in biotechnology and biopharma fields, while Dr Starrs’ team covers organic chemistry and pharma. Both contribute to policy and practice development in these technical fields.

| BIOSCIENCE TODAY |

| news |

Cancer Research UK tackles global cancer challenges with £60 million in funding Cancer Research UK announced that it is funding three major new international research initiatives on the microbiome, chronic inflammation and why some cancers are specific to certain tissues and not others. Multidisciplinary teams of scientists from across North America, the UK and Europe, and Israel will come together to explore these research challenges, which are currently some of the biggest in cancer research. Collectively, the teams have been awarded almost £60 million. These five-year research programmes will investigate how billions of microorganisms living in our bodies, called the microbiome, could be manipulated to treat bowel cancer; find new ways to tackle cancers linked to chronic inflammation; and develop a deeper understanding of why cancers develop in some tissues but not in others. These initiatives represent the bold approach Cancer Research UK is taking in bringing the very best researchers from around the globe together to unite their talent, pool resources and crack some of the biggest questions in cancer research. And for the first time, several major US institutions will be leading these projects as part of the Grand Challenge competition. They are the Brigham and Women’s Hospital, Harvard Medical School, Boston; Dana-Farber Cancer Institute, Boston; Harvard T.H. Chan School of Public Health, Harvard University, Boston; and the University of California, San Francisco. They form part of a growing community of Cancer Research UK funded international researchers. Dr Iain Foulkes, Cancer Research UK’s executive director of research and innovation, said: “Individually, these research teams are among the best in the world in their respective fields. By bringing them together across borders, Grand Challenge is enabling these teams to think bigger and establish new and exciting collaborations. The scale of the funding reflects the opportunity we see in harnessing their ability to understand and tackle cancer.”

MANIPULATING THE MICROBIOME TO BEAT BOWEL CANCER Bowel cancer is the 4th most common cancer in the UK, accounting for 12% of all new cancer cases in 2015. Initial research suggests that a person’s microbiome – the collection of billions of microorganisms living in our bodies – may be linked to bowel cancer and their response to treatment. Professor Matthew Meyerson at the Dana-Farber Cancer Institute and Harvard Medical School, and Professor Wendy Garrett at the Harvard T.H. Chan School of Public Health will lead the project, along with researchers in the US, Canada, the UK, the Netherlands and Spain, to explore the relationship between the microbiome and bowel cancer.

FINDING NEW WAYS TO TACKLE CANCERS LINKED TO CHRONIC INFLAMMATION In another project, Professor Thea Tlsty at the University of California, San Francisco, and collaborators from the US, Canada, the UK and Israel will unravel how chronic inflammation is linked to cancer.

UNDERSTANDING WHY CANCERS GROW IN SOME TISSUES BUT NOT OTHERS Professor Stephen Elledge at the Brigham and Women’s Hospital, Harvard Medical School and collaborators from the US, the UK and the Netherlands are looking to understand why genetic faults only affect certain tissues. This project is supported in partnership with The Mark Foundation for Cancer Research. These teams will now join a growing community of Grand Challenge researchers, which first launched in 2015 and already includes four international teams announced in 2017. Grand Challenge is open to scientists based anywhere in the world and from any discipline to bring innovative, international, and collaborative approaches to research. The funding for these new projects comes from Cancer Research UK directly and with support from The Mark Foundation for Cancer Research, based in New York, which are providing £10 million to the project led by Professor Stephen Elledge. Michelle Mitchell, Cancer Research UK’s chief executive, said: “We’re excited to be able to fund such innovative research. These teams have five years to try to answer these complex questions about a disease that affects so many people, and we look forward to crossing new frontiers in our understanding of cancer. “To reach our ambition of 3 in 4 people surviving their cancer by 2034, we need to collaborate not only with researchers from across the globe, but with funders in other countries who share our goals. Grand Challenge provides a perfect opportunity for us to partner with organisations like The Mark Foundation for Cancer Research and pool our resources to fund research that will transform the lives of patients with cancer.”

| news |

| BIOSCIENCE TODAY |

£200 million to boost mental health research Funding to bring researchers together to improve understanding and treatments for depression and anxiety Wellcome is committing an additional £200 million to mental health research, Wellcome’s Director announced at the World Economic Forum in Davos, Switzerland. Mental health has a high profile at Davos this year with the Duke of Cambridge, Prince William and Prime Minster of New Zealand, Jacinda Ardern speaking at a public session on mental health. Dr Jeremy Farrar, Director of Wellcome, said: “Mental health affects everyone, either directly or through our relatives and close friends. There has been great progress in improving awareness over the last few decades but too many people are still left behind. We know too little about the underlying causes, how treatments work, why they work for some and not others, and how to make them more effective. “Science is essential to answering these questions, which is why Wellcome is committing £200 million over the next five years. To take on this huge challenge, we need broad expertise, with researchers from different backgrounds and experiences, and different countries, alongside governments, businesses and wider society.

To transform how depression and anxiety are treated, Wellcome aims to: find new ways to ‘back translate’ successful psychological therapies, so that the biological and neurophysiological mechanisms underpinning them are better understood develop common standards for how depression and anxiety are assessed, to enable consistency and comparison between different groups Create a new global database to host mental health data, to enable researchers to carry out large-scale analytics and encourage them to collaborate on key challenges: for example, to differentiate between different types of depression. Wellcome is one of the world’s biggest funders of mental health research, providing over £300 million in funding over the last ten years. Alongside the additional £200 million, Wellcome will continue to fund neuroscience and mental health research through its usual science funding schemes.

“Mental health is not just a pressing public health problem, it’s also a huge productivity and economic issue. Far less is spent on mental health research than on physical health. More investment is essential to develop and improve treatments, get these to the people who need them and reduce the stigma that tragically surrounds mental health issues. There is a great opportunity to innovate and transform our mental health, in everything from basic research and early prevention, to frontline treatment and workplace initiatives.” Wellcome’s new five-year programme will focus on improving basic understanding of depression and anxiety to improve treatments – supporting research into what works and why, and how best to tailor treatments to the individuals who need them. It will concentrate on psychological therapies that can be delivered early in life and early in the onset of illness, as mental health problems typically start at a young age. Over 615 million people suffer from anxiety and depression worldwide. Depression and anxiety often go untreated, especially in low-income countries, and treatments are only effective for around half of people. Clinicians often have to use trial and error to work out the best treatment, without being able to explain why one person’s treatment is different to another’s. Mental health research is fragmented, with researchers often working in silos, and mental health problems described and measured in different ways. Wellcome aims to bring together different groups of researchers – including psychiatrists, neurologists and, public health specialists, neuroscientists, data scientists and cell biologists - to share knowledge and collaborate. The goal is to create a culture like that of cancer research, where seamless collaboration across basic and social science, clinical medicine and public health have helped to drive new approaches to treatment and prevention and much better health outcomes.

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Physical exercise linked to cognitive health Researchers in the US have found that older adults who are more physically active in later life have better memory and thinking skills. They also found that this association was not affected by having Alzheimer’s or signs of other neurodegenerative diseases. The results have just been published in the medical journal, Neurology. Dr David Reynolds, Chief Scientific Officer at Alzheimer’s Research UK, said: “Keeping physically active has been linked to a range of health benefits including better cognitive health and a lower risk of dementia, but we don’t understand the biological mechanisms that explain how physical activity could limit a decline in memory and thinking. “While some previous research suggests that exercise could reduce the development of brain changes involved in diseases like Alzheimer’s, this study found that physical activity was linked to better memory

and thinking skills even when the researchers took Alzheimer’s brain changes into account. “One possible explanation for these findings is that people with worse memory and thinking skills simply tend to be less active. The best way to establish cause and effect in this relationship is with carefully controlled long-term trials that are designed to sift out the effects of exercise from the myriad of other factors that could affect brain function over time. “Alzheimer’s Research UK is now funding work to see how feasible it is for people in midlife to take up exercise as part of a healthier lifestyle, with a view to larger trials that assess the effect on brain health. “The best current evidence indicates, in addition to staying physically active, not smoking, controlling blood pressure and cholesterol, only drinking in moderation, eating a balanced diet, and staying mentally active are linked to better brain health as we age.”

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Queen’s University Belfast awarded 6.1 million euros to address fertility issues Queen’s University Belfast have been awarded 6.1 million euros, in collaboration with 11 other global partner universities and institutions, to develop a test to identify harmful chemicals that affect female fertility. The grant is part of a wider research project funded by the European Research and Innovation programme Horizon 2020 to develop highly needed test methods to identify harmful chemicals, known as endocrine disruptors. The tests will be used to address a range of health issues affecting humans, animals and the environment. Endocrine disruptors are chemicals that can interfere with hormones and are found in everyday products such as plastics, air fresheners and cosmetics. Without dedicated tests to assess endocrine disruptor properties, it is difficult to gauge the damage these chemicals can have on humans, animals and the environment. Better test methods will help protect the health of humans and the environment. In humans, endocrine disruptors can affect fertility and brain development.

Animals can be affected by endocrine disruptors in the environment. For example, male fish are increasingly carrying female eggs caused by the release of endocrine disruptors released by waste water treatment plants. Researchers at Queen’s University and Vrije Universiteit, Netherlands have been awarded 6.1 million euros to develop a test on assess how endocrine disruptors can affect a women’s fertility (through the FREIA project). Dr Lisa Connolly at Queen’s University Institute for Global Food Security, co-author on the study explained: “There is surprisingly limited knowledge on this issue. We will investigate how exposure to endocrine disruptors during different hormone-sensitive phases in a woman’s life such as the fetal, puberty, and adult stages, can ultimately affect her fertility.” The main aim of this project is to develop tests for humans to identify the chemicals that can cause damage to the female reproductive system. Dr Connolly added: “We are delighted to be part of this research project which brings together experts across a number of countries. It is only through developing a test to better understand how these chemicals affect fertility that we will then be in a position to offer solutions.”

“There is surprisingly limited knowledge on this issue. We will investigate how exposure to endocrine disruptors during different hormone-sensitive phases in a woman’s life such as the fetal, puberty, and adult stages, can ultimately affect her fertility.”

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New treatments for severe asthma to be studied A £2.68 million study to investigate the effective use of antibiotics to treat certain types of severe asthma is being spearheaded by researchers in Leicester. The project, which is funded by the National Institute for Health Research (NIHR) and Medical Research Council (MRC), and part designed by asthma patients through a partnership with Asthma UK, represents one of the largest ever awards by their Efficacy and Mechanism Evaluation programme to a national clinical trials consortium. It is estimated that around 1 in 20 people with asthma have severe asthma. This typically presents as a high number of symptoms and poor lung function - despite regular medications - and repeated asthma attacks that frequently require time off work and admission to hospital. Severe asthma is an umbrella term for several different disease types, which can be identified using blood tests (biomarkers). Many patients with severe asthma find that regular oral steroids have multiple intolerable side effects, including difficulty sleeping, weight gain, changes in mood, diabetes, weakening of the bones, high blood pressure and eye conditions such as glaucoma and cataracts, and wish to stop taking oral steroids as early as possible. Chief Investigator for the study, Professor Salman Siddiqui, is a Professor of Airway Diseases at the University of Leicester and Consultant Respiratory Physician at Leicester’s Hospitals. He said: “In this study we will work with severe asthma specialist centres in the UK to identify patients who experience frequent asthma attacks, which we define as two or more per year. “We will then take a blood test that measures blood eosinophil level (a type of blood cell associated with inflammation) to identify two important subtypes of severe asthma. The first subtype of interest to us is called “T2HIGH” severe asthma and might be driven by high numbers of eosinophils in the blood that then move to the airways in the lungs and may cause asthma attacks. The second subtype is called “T2-LOW” severe asthma and might be caused by bacteria living in the lungs and how they work

with the immune cells. Depending on which type of severe asthma patients have, they will be split into two arms of the study.” The national charity, Asthma UK, has led patient involvement in the development and design of the trial and will continue to include patients with severe asthma for the duration of the study, with the support of patient representative, Val Hudson. Two national workshops were held to ensure the patients’ voices were heard in the development of the grant. Asthma UK, which funds research into asthma and provides a nurse helpline to people with asthma, also consulted with the European asthma community, who all agreed this is valuable research. Mrs Hudson said: “When you are involved as a patient in a clinical trial, both as a member of a patient input platform or as a trial participant, you are aware that you are not likely to personally benefit from the trial results but you hope that you will make a difference to people in the future with severe asthma. “Asthma UK has over 15 years’ experience in involving people with asthma in research which has helped shape and drive the design and delivery of studies. It is vital that people with asthma are involved at all stages of research as they provide invaluable insight into their experiences and ensure that studies have the biggest possible impact.” The trial includes industry partners Knopp Biosciences and AstraZeneca. It is hosted by the Leicester Clinical Trials Unit and sponsored by the University of Leicester. Professor Gavin Murphy, Head of the Leicester Clinical Trials Unit, said: “We at the Leicester CTU are delighted to be working with Salman and his collaborators on this landmark trial that will provide new and important knowledge that should improve the lives of patients with severe asthma.” The Efficacy and Mechanism Evaluation programme funds ambitious studies evaluating interventions with the potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care. It is a partnership between the NIHR and the MRC.

POSTGRADUATE STUDY FOR LIFE SCIENCES GRADUATES WHERE NEXT WITH YOUR DEGREE? If you have studied a life science subject such as biomedical science, microbiology, genetics, anatomy or biology then the University of Birmingham may offer the perfect postgraduate programme to help you take your next step. We offer a variety of programmes to suit your individual needs and interests, backed up by the academic expertise, facilities and influence of a global university. To find out more get in touch at one of our Open Days (either on campus or virtually). At the University of Birmingham we offer a wide range of over 30 postgraduate programmes suitable for recent life science graduates including:

MASTERS PROGRAMMES n n n n n n n n n n n n n

Bioinformatics Clinical Neuropsychiatry Dental Materials Science Genomic Medicine Health Economics and Health Policy Health Research Methods Immunology and Immunotherapy Microbiology and Infection Molecular Biotechnology Physician Associate Public Health Toxicology Trauma Science

MASTER OF RESEARCH PROGRAMMES n n n n n n

Cancer Sciences Clinical Health Research Biomedical Research: Integrative and Translational Biomedical Research: Cardiovascular Sciences Molecular and Cellular Biology Molecular Mechanistic Toxicology

We also offer a wide range of PhD programmes.

STAY IN TOUCH We offer several opportunities for you to find out more with campus-based Open Days, Virtual Open Days and of course, you can always email or call.

OPEN DAY

20 March 2019 Our Postgraduate Open Day will give you the best opportunity to hear firsthand from our current students and staff about our Masters and research opportunities. You can register online to keep up to date with which programme will be represented.

VIRTUAL OPEN DAY If you canâ&#x20AC;&#x2122;t make it onto campus we also have a set of subject-specific Virtual Open days running in March. This will give the opportunity to chat online with the programme lead and watch videos about the programmes. You can register online to find out more. To register for open days and for information about individual programme visit: www.birmingham.ac.uk/ pg-life-sciences

www.birmingham.ac.uk/pg-life-sciences

WHERE ARE THEY NOW? Our students are our best voice so we have included a few profiles below. To access more profiles of our postgraduate students please visit: www.birmingham.ac.uk/pg-life-sciences

MSC TRAUMA SCIENCE

‘

The opportunities given to me by far have been the best thing about the course. All the lecturers that have taught so far have come from different specialities and each have their own input into this course. They have offered me the opportunity to shadow them in the hospital and gain an exceptional experience.

Nirali is a MSc Trauma Science student who also holds a degree in Biomedical Science. She is keen on pursuing a degree in Medicine in the future. She currently works as a medical laboratory assistant in London and volunteers at many organisations.

To read Nirali’s full profile or ask her a question visit: pg.bham.ac.uk/mentor/n-patel/

MRES MOLECULAR AND CELLULAR BIOLOGY

‘

For me, I really wanted to gain more practical lab experience in biology after my undergraduate and see whether a career in research was for me. Doing an MRes has allowed me to work in two different labs throughout the academic year and gain a vast amount of experience in different areas of biology in terms of research topics and techniques.

Jagjeet is a full-time research student, who completed her MRes in Molecular and Cellular Biology at the University of Birmingham. She is currently studying towards a PhD in Immunology and Immunotherapy at Birmingham, having completed her undergraduate degree in Biological Sciences with Professional Placement at Aston University, which included an Erasmus placement in France.

To read Jagjeet’s full profile or ask her a question visit: pg.bham.ac.uk/mentor/j-kaurs/

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A golden era for

blood

cancer treatments It’s an exciting time in blood cancer research. As we deepen our understanding of the biology of blood cancer, researchers are developing better treatments than ever before, and we’re even beginning to talk about cures for some types of blood cancer where it would have been unthinkable a decade ago. Let’s take a look at the brilliant progress that’s been made in the past few years… Clare Jonas

Research Communications Officer, Bloodwise

CAR-T: A CURE FOR BLOOD CANCERS? CAR-T is a new treatment that can put blood cancer into remission or cure it – even in people who would otherwise have only a few months to live. Not only that, CAR-T cells should be able to prevent relapses, since they are designed to remain active in the body for a long time. This completely new approach to tackling blood cancer works by taking T cells from patients, adding a chimeric antigen receptor (CAR) that can bind to cancer cells, then returning these CAR-T cells to the patient via an infusion. Back in the bloodstream, the CAR-T cells can hunt down and kill cancer cells with much greater efficiency than the patient’s unmodified T cells. Last year, CAR-T therapy was made available on the NHS to children and young adults with B-cell acute lymphoblastic leukaemia as well as adults with diffuse large B-cell lymphoma or primary mediastinal B-cell lymphoma – though only those who have exhausted all other treatment options. The first patient in the UK was treated just before the end of the 2018. CAR-T isn’t without its problems: the major hazard to patients is from cytokine release syndrome in the days immediately following a CAR-T cell infusion, and since it’s a relatively new treatment we don’t know what the longer-term side effects of the procedure are. However, the danger of cytokine release syndrome can be mitigated by keeping patients under observation following the infusion procedure, and follow-ups from clinical trials are keeping an eye on the long-term progress of people who’ve had the treatment. A second set of problems relate to the cost and limitations of the CAR-T treatment itself. The only versions available currently require the modification process to be carried

out anew with T cells from each individual. On top of that, CAR-T is only available to people who have cancers affecting B cells, since we can’t yet arm T cells to attack other T cells. There are researchers working on each of these problems, developing CAR-T treatments for other types of cancer, and Bloodwise is funding research on a ‘universal’ CAR-T therapy that doesn’t need to be made afresh for each individual. This universal therapy is also designed to treat T cell acute lymphoblastic leukaemia.

ACUTE MYELOID LEUKAEMIA: TARGETED TREATMENTS It’s not just CAR-T where breakthroughs are being made. For a long time, finding ways to effectively treat acute myeloid leukaemia (AML) have been among the most intractable problems in blood cancer research. AML’s symptoms (fever, fatigue, shortness of breath, for example) can easily be confused with ‘feeling generally unwell’, which can delay diagnosis of this rapidly-developing cancer. This means that at the point when a clinician confirms that a patient has AML, treatment is often urgently needed. Unfortunately, there are several different genetic mutations which can cause the disease, and it can take a few days to find out which of these is in play in order to provide the correct targeted treatment. If the patient can’t afford to wait, or a targeted treatment doesn’t exist for the type of AML they have, then the only other option is intense and toxic chemotherapy, which not everyone is healthy enough to tolerate. Chemotherapy has been the mainstay of AML treatment for decades, but in 2018 we saw several new targeted treatments become available. This is great news, but the drugs are limited to a small population of AML patients, and an increase in the number of targeted treatments means that matching up the right treatment to the patient is now more important than ever before. This is where the BEAT AML Master Clinical Trial comes in. The trial is for people over 60 with newly diagnosed AML,

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and its aim is to match a targeted drug to each person’s AML within 7 days. Of the 350 people who’ve taken part in this trial, 95% have been assigned a new targeted therapy. Having a test that can quickly match kinder treatments to each individual person will have a major impact on survival time, especially for those who are unable to tolerate intense chemotherapy. We’re also expanding the number of targeted treatments available through a study we have funded on the genetics behind different types of AML. This research has revealed the critical founder mutations that act as trigger points for the development of different types of AML. Because cells with the same founder mutations always follow the same development pathway, the researchers were able to identify key places to target individual types of AML. We could soon be looking at individualised treatment for all forms of AML, not just a few.

CHRONIC LEUKAEMIAS: ON THE CUSP OF A CURE Unlike acute blood cancers, chronic blood cancers are generally slow-growing, but need to be monitored and kept in check to prevent or slow further development. Before 1998, the only way to treat chronic myeloid leukaemia (CML) that had reached an advanced stage was with a stem cell transplant. The advent of tyrosine kinase inhibitors (TKIs), which can be taken as a daily pill, changed CML from a potentially fatal condition to one with a normal life expectancy for most patients. Unfortunately, TKIs can cause many unpleasant side effects like fatigue, diarrhoea and headaches, and until recently it was thought that everyone taking TKIs would need to do so for life. In the last two years, the Bloodwise-funded DESTINY trial has made it clear that at least some people whose CML is stable or at undetectable levels in tests can slowly reduce and eventually stop taking TKIs without long-term risk of relapse. For those whose CML does relapse, resuming TKIs

can swiftly return them to a state of deep remission. This exciting finding is unlikely to apply to everyone, but it will help change the way doctors treat people with CML who are doing well on their TKIs, giving them the wonderful prospect of being free from their medication and its side effects. Things are looking even more promising for people with chronic lymphocytic leukaemia (CLL), which has historically been treated with chemotherapy and/or immunotherapy. However, a new generation of targeted drugs is changing the way we treat CLL. A combination of two of these targeted drugs – ibrutinib and venetoclax – is showing great promise in the Bloodwise-funded CLARITY trial, for people with CLL that has not responded to other treatments. Remarkably, every single one of the 50 people who’ve taken part in this trial has responded to treatment, with some doing so well that they have been able to finish treatment and remain in remission. We might, at last, be looking at a cure for this cancer.

THE FUTURE Although we have seen some amazing breakthroughs in blood cancer recently, death rates for some blood cancers remain very high, and there is still much to do. One in 19 of us will have a blood cancer at some point in our lives, and blood cancer is the third biggest cancer killer in the UK, claiming over 15,000 lives every year – more than breast cancer or prostate cancer. To keep up the momentum of the improvements we have seen in the last few years, and for those improvements to apply to more blood cancers, we need to make sure that investment in blood cancer research continues. bloodwise.org.uk

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Out of this The UK Space Agency and NHS England are currently judging ideas for how technology originally designed for space could help solve major health and care challenges facing the NHS. With up to £4 million available from the UK Space Agency, the competition, in collaboration with NHS England, focuses on tackling the four main challenges facing the National Health Service: Managing long term conditions including joining up health and care services Earlier diagnosis of cancer Transforming GP services and other primary care Meeting mental health needs As the UK space sector grows so does its technology. The competition allows innovators to bid for money to turn space technology into life changing health care solutions. A number of applications will receive funding from the UK Space Agency in company with support and guidance from NHS England and the European Space Agency (ESA). Emily Gravestock, UK Space Agency head of applications, said: “I am delighted with the number and calibre of entries into the NHS call for funding. The variety of ideas, and the innovation shown by the entrants has been enormous and ideas have come in from all areas – clinicians, the public and from industry. “I am excited about working with ESA and NHS England to judge these ideas, to bring the best ones into reality, and, ultimately, to improve patient care.” The UK space sector is growing rapidly, with world-leading space manufacturing capabilities and a 40% share of the global export market in small satellites. To maintain those numbers the sector supports 40,000 jobs and generates £14 billion in revenue. Past examples of space technology being adapted for the NHS have revolutionised numerous areas within health care, such as pill cameras that can be swallowed by patients, dementia tracking slippers, apps that help prevent skin cancer and wearable monitors for the elderly to help prevent falls. Professor Tony Young, national clinical director for innovation at NHS England, said: “The NHS has a long and impressive track record of world class innovation that improves patient care - from hip replacements to vaccines, medical scans to organ transplants and now genomics.

“As we prepare to set out a long term plan for our health service, this competition is helping us drive the use of innovative space technology to see if it can bring benefits for our patients.” Converted space technology that is already helping the NHS includes: Dementia tracking slippers: People in Dorset who are affected by dementia are trialling GPS soles to try and reduce hospital admissions. The discreet tracking tool can sit inside everyday footwear and alerts carers if the patient wanders outside their set parameters or ‘geo-fence’. The alert is sent via an app on an internet enabled device with the location of the wearer. This allows them to be found quickly and reduces the chance for them to encounter any harm. This simple device allows heightened independence to the wearer and peace of mind for the carer. A pill-sized camera to diagnose gut problems: The video capsule endoscopy or pill cam is an approximately 2cm long device used to examine the lining of the small intestine. The capsule contains a miniature video camera and light source. This small capsule can help investigate anaemia, unexplained bleeding, suspected coeliac disease and abnormalities such as polyps. All while travelling painlessly through the patient, capturing images and sending them to a recording device for analyse by a clinician. Tech to help prevent falls inspired by NASA: A wearable monitor which uses microelectromechanical (MEMS) gyroscope equipment, which was partly based on the breakthroughs of America’s space programme to monitor how people walk, is helping vulnerable and elderly people to avoid falls. A short 10 minute assessment with a physiotherapist can prescribe a personalised exercise programme to reduce the risk of falls. Skin cancer app: Apps that use satellite technology can give a personalised risk assessment of your sun exposure, like the Happy Sun App. This could form part of care packages in the near future and to help inform patients of how to stay their safest in the sun.

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world

â&#x20AC;&#x153;As we prepare to set out a long term plan for our health service, this competition is helping us drive the use of innovative space technology to see if it can bring benefits for our patients.â&#x20AC;?

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Research at the interface of technology and life sciences The Institute of Aerospace Medicine at the German Aerospace Center (DLR) comprises departments in Cologne and in Hamburg with internationally unique research infrastructure. At DLR, the Institute serves as interface between sophisticated technology and biology, medicine, and psychology. The research is conducted in close collaboration with leading national and international research institutions. The long-standing experience of the Institute in selecting and caring for pilots, air traffic controllers, and astronauts in particular directly after return to Earth provides a solid foundation guiding our research efforts. Systematic ground-based studies in radiation, astro- and gravitational biology are performed in the planetary and space simulation facilities of the Institute and are complemented by successful investigations in space over many years.

Professor Jens Jordan

Director of the Institute of Aerospace Medicine

FROM BIOMEDICAL AND PSYCHOLOGICAL RESEARCH IN SPACE AND IN AERONAUTICS TO APPLICATIONS ON EARTH In space and in aeronautics, human beings are exposed to extreme environmental stresses affecting wellbeing and performance. During prolonged manned space missions, these challenges jeopardize crew health as well as the success of the mission. Fainting and fall risk which can be easily managed after return to Earth could have catastrophic consequences on another celestial body. The primary goal of our research is to elucidate the underlying mechanisms and to develop diagnostic tests predicting psychological and medical risks early on. The mechanistic insight guides our efforts to develop targeted medical and psychological countermeasures.

Many of the challenges in space and in aeronautics are highly relevant for human beings on Earth. For example, in the absence of sufficient countermeasures, space travel replicates many of the physiological changes associated with ageing including loss of musculoskeletal function, cardiopulmonary fitness, coordination, and ocular health among others. Increased radiation exposure elicits premature ageing at the cellular level. For example, radiation damage to epithelial cells maintaining ocular lens fibers promotes cataract formation, a condition observed at an older age in people on Earth. The potential for radiation exposure during spaceflight to induce tumor formation, cardiovascular disease, and damage to critical structures in the central nervous system is an area that needs to be addressed to gauge risks of long-term missions in outer space. The repair mechanisms maintaining cell integrity after radiation exposure also mitigate damage elicited through other environmental challenges, making this research relevant for people on Earth.

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“Our Institute has longstanding experience conducting research under space conditions. For example we assess cardiovascular and musculoskeletal function in astronauts and in cosmonauts on the Internationals Space Station.” Both, space travel and long distance flights over several time zones perturb circadian rhythms and sleep, which in addition to affecting health may limit human performance and promote critical errors. Insufficient duration and poor quality of sleep are also recognized as an increasing health risk on Earth. Indeed, short sleep duration has been linked with increased risk for cardiovascular and metabolic disease. Another important research area is devoted to selecting individuals for highly demanding professions, including astronauts, pilots, and air traffic controllers. The goal is to identify individuals who will be able to cope with specific technological and interpersonal tasks. Demographic changes, particularly ageing populations, coupled with shortage of skilled workers, and increasing internationalization are challenges actively investigated in aerospace psychology with applications in many other professional areas. For example, we now apply the

methodologies developed in aerospace psychology for selection of medical personal.

THE NEED FOR UNIQUE SCIENTIFIC MODELS ON EARTH Our Institute has longstanding experience conducting research under space conditions. For example we assess cardiovascular and musculoskeletal function in astronauts and in cosmonauts on the Internationals Space Station. The biological research involves experiments on the International Space Station, on compact satellites, research rockets, and parabolic flights. However, the availability of astronauts and cosmonauts for biomedical and psychological research projects is limited. Procedures that are easy to conduct on Earth, such as blood drawing, pose major issues while in space. Furthermore, research equipment for space has to be specifically developed and certified and is difficult and expensive to transport. Mechanism-oriented research is also limited in

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 Continued from page 21 operators of aircrafts albeit to a lesser degree. Therefore, biomedical research in space and in aeronautics has to be complemented by sophisticated simulations on Earth. Therefore, our Institute developed internationally unique expertise and research infrastructure for human studies under highly controlled environmental conditions. Opening of the :envihab – the name is derived from environment and habitat – research facility in 2013 was a great leap in that direction. The goal was to enable highly standardized simulations of environmental factors in human beings. The environmental conditions covered by our research include atmosphere composition and pressure, gravitation, noise, light, radiation, nutrition, and the microbiome. Bedrest studies in the head-down position – one of the workhorses in space medicine – are conducted in collaboration with international space agencies. The model produces fluid shifts in the body towards the head resembling changes observed in weightlessness. Much like astronauts, participants experience reductions in muscle and bone mass and physical performance. Through the head-down bedrest model, countermeasures can be tested on Earth before they are applied during space travel. Isolation imposes major challenges to psychological health and could conceivably endanger space missions. Therefore, isolation experiments on Earth are actively pursued to better understand the psychological traits and interpersonal risk factors affecting the response of a crew to this condition. The :envihab is equipped to conduct sophisticated isolation experiments. Perhaps, crews more or less resilient to withstand isolation can be prospectively identified. Technology might aid in relieving the negative impact of isolation on astronauts.

HIGH-FIDELITY HUMAN PHENOTYPING Human experiments in space and in human models on Earth are necessarily conducted in relatively small samples. In contrast, clinical studies in terrestrial medicine may include hundreds or even thousands of patients. Therefore, we developed methodologies allowing for precise and comprehensive human investigations, so called high-fidelity human phenotyping. The engineering expertise at DLR allows for development of technologies that are not available off the shelf. The modular concept of :envihab enables research on various aspects of human physiology including sleep, circadian rhythms, bone and muscle physiology, microbiological and molecular biological research under highly controlled and variable environmental conditions. The combination of advanced human physiology profiling, state-of-the-art imaging modalities, and highly standardized simulation and manipulation of environmental conditions are particular strengths of our research.

TRANSLATION FROM CELLS TO HUMANS AND BACK TO CELLS Our medical research in human beings is flanked by studies at the cellular level. For example, we study cellular responses to radiation damage with the goal to derive novel preventive measures. Similarly, we developed unique methodologies to investigate cellular responses to gravity. In particular, we are interested in how mechanical forces are sensed, transduced, and integrated at the cellular level. In addition to providing insight in fundamental biology, the research is relevant for human physiology and medicine. Indeed, cellular mechanotransduction affects cardiovascular and musculoskeletal structure and function among others.

The :envihab also hosts ESA astronauts directly after their return from the International Space Station to Earth.

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AI approach outperformed human experts in identifying cervical precancer Algorithm could revolutionize cervical cancer screening, especially in low-resource settings A research team led by investigators from the National Institutes of Health and Global Good has developed a computer algorithm that can analyze digital images of a woman’s cervix and accurately identify precancerous changes that require medical attention. This artificial intelligence (AI) approach, called automated visual evaluation, has the potential to revolutionize cervical cancer screening, particularly in low-resource settings. To develop the method, researchers used comprehensive datasets to “train” a deep, or machine, learning algorithm to recognize patterns in complex visual inputs, such as medical images. The approach was created collaboratively by investigators at the National Cancer Institute (NCI) and Global Good, a fund at Intellectual Ventures, and the findings were confirmed independently by experts at the National Library of Medicine (NLM). The results appeared in the Journal of the National Cancer Institute on January 10, 2019. NCI and NLM are parts of NIH. “Our findings show that a deep learning algorithm can use images collected during routine cervical cancer screening to identify precancerous changes that, if left untreated, may develop into cancer,” said Mark Schiffman, M.D., M.P.H., of NCI’s Division of Cancer Epidemiology and Genetics, and senior author of the study. “In fact, the computer analysis of the images was better at identifying precancer than a human expert reviewer of Pap tests under the microscope (cytology).” “The new method has the potential to be of particular value in low-resource settings. Health care workers in such settings currently use a screening method called visual inspection with acetic acid (VIA). In this approach, a health worker applies dilute acetic acid to the cervix and inspects the cervix with the naked eye, looking for “aceto whitening,” which indicates possible disease. Because of its convenience and low cost, VIA is widely used where more advanced screening methods are not available. However, it is known to be inaccurate and needs improvement. Automated visual evaluation is similarly easy to perform. Health workers can use a cell phone or similar camera device for cervical screening and treatment during a single visit. In addition, this approach can be performed with minimal training, making it ideal for countries with limited health care resources, where cervical cancer is a leading cause of illness and death among women.

To create the algorithm, the research team used more than 60,000 cervical images from an NCI archive of photos collected during a cervical cancer screening study that was carried out in Costa Rica in the 1990s. More than 9,400 women participated in that population study, with follow up that lasted up to 18 years. Because of the prospective nature of the study, the researchers gained nearly complete information on which cervical changes became precancers and which did not. The photos were digitized and then used to train a deep learning algorithm so that it could distinguish cervical conditions requiring treatment from those not requiring treatment. “When this algorithm is combined with advances in HPV vaccination, emerging HPV detection technologies, and improvements in treatment, it is conceivable that cervical cancer could be brought under control, even in lowresource settings,” said Maurizio Vecchione, executive vice president of Global Good. The researchers plan to further train the algorithm on a sample of representative images of cervical precancers and normal cervical tissue from women in communities around the world, using a variety of cameras and other imaging options. This step is necessary because of subtle variations in the appearance of the cervix among women in different geographic regions. The ultimate goal of the project is to create the best possible algorithm for common, open use. About the National Cancer Institute (NCI): NCI leads the National Cancer Program and NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at cancer. gov or call NCI’s Contact Center, the Cancer Information Service, at 1-800-4-CANCER (1-800-422-6237). About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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Matching clinical trials with unmet clinical need A new tool that helps target clinical trials to areas of unmet clinical need has sparked interest in both the National Health Service (NHS) and the commercial clinical research world. Stephen Lock, Head of Business Intelligence for the National Institute for Health Research (NIHR) Clinical Research Network, reveals why. For over a decade the NIHR Clinical Research Network has been recording the clinical research activity in England and tracking its growth and expansion. Innovative approaches to how we use this data are now presenting new opportunities to improve research delivery and to help maintain the UK’s position as a key global destination for clinical research. To understand why, we first need to understand the role of the NIHR Clinical Research Network. The easiest way is to think of it as the clinical research arm of the NHS. This unique government-funded research infrastructure is embedded throughout the entire NHS, reaching into both primary and secondary care. It provides the people, resources and support needed to carry out clinical research in the NHS with the ultimate aim of developing better treatments for patients. Last financial year our organisation helped recruit over 725,000 participants into 4901 clinical research studies - which makes us the biggest recruiter of research participants in the world. We’ve been recording this type of research activity since 2006 so, as you can imagine, we are what you might call a “data-rich” organisation. As with most organisations, our original purpose for capturing data was performance monitoring and management of resources. The organisation comprises 15 Local Clinical Research Networks which cover the whole of England. We also organise our work through 30 medical specialty areas including everything from ageing, cancer and diabetes, to respiratory, stroke and surgery - and many more inbetween. Comparing research activity in these different regions and categories certainly helps us to direct our resources to where they were most needed, look at what we have achieved, and look at where there might be room for improvement. More recently we’ve found that the data we collect has proved an important asset in our public-facing campaigns which aim to help raise awareness of the importance of clinical research. For example, for the last seven years we have published NHS research activity league tables which enable members of the public to see exactly how much research is being conducted in their local NHS trust, be that acute, mental health or ambulance trusts.

As our Business Intelligence capabilities have matured we’ve found that the data that we collect is becoming ever more valuable. This data needs to be managed, maintained and interpreted by a wide range of stakeholders to drive research delivery and continuous improvement in the clinical research environment spanning the NHS, academia and the life-sciences industry. In 2013 we launched our Open Data Platform (ODP) which allows NIHR employees and other specific stakeholders to explore up-to-date study and recruitment data on their PC or mobile device. It’s a self-service business intelligence tool that increases visibility and improves the visualisation of data from separate information systems into simplified dashboards, or apps as we prefer to call them. The different apps allow users to interact with high level or granular information to suit their information, analytical and reporting needs. This is useful for gaining insight and predicting what might happen in the future. But in 2018 we took the next logical step and we’re now looking at how our data can help our customers and partner organisations make decisions about what should happen in the future. The real “Aha” moment came when a colleague produced a heat map of NHS research activity broken down by Clinical Commissioning Group (CCG) areas (these are clinicallyled statutory NHS bodies responsible for the planning and commissioning of health care services for their local area). We’d already learned that looking at our data through different lenses gave us different insights, but the granularity of this view of our data resembled the granularity of disease prevalence heat maps and other similar data provided by the Office for National Statistics and Public Health England. This immediately begged the question: What would we learn if we directly compared disease prevalence to research activity in a specific specialty or condition? What we discovered was a game-changer. Several conversations ensued with the clinical community, life science industry and other partner organisations. The potential benefits were clear and development of a Research Targeting Tool was prioritised. Within six months we had a working prototype added to our suite of apps on our Open Data Platform.

The Research Targeting Tool helps researchers to place their clinical research studies and trials intelligently

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Judith Holliday, Head of Research and Innovation at Mid Yorkshire Hospitals NHS Trust, is a big fan of the Research Targeting Tool. I first discussed the concept with her about six months before the tool was launched. She says:

demonstrates, there is a lot of untapped potential here in West Yorkshire. Having this type of information available so easily will help us to bring clinical studies to those patients that need them.”

“Stephen initially came to me with an idea and the advantages of having access to the Research Targeting Tool, as he described it, were immediately obvious to me.

Life science companies are also beginning to have similar conversations with us. During the autumn of 2018 we demonstrated the tool at a number of conferences and meetings and after each session my colleagues and I were inundated with questions from companies like Johnson & Johnson and Covance.

“Our annual process for identifying the Trust’s research priorities for the year ahead can be quite complex. We have to take into consideration a number of practical things such as ongoing research activity and the availability of research skills and experience. This helps us to establish where the capacity exists. But also we have to ask: Where is the clinical need? Which patients might benefit most from having opportunities to take part in clinical studies and gaining access to new treatments? “My trust covers three sites: Pinderfields, Dewsbury and Pontefract. All these areas were previously home to collieries, and therefore have a large ex-mining population. Consequently, we currently have a high incidence of respiratory disease, for example COPD. Yet historically we have had very low levels of respiratory research - just one small commercially-funded study in the last 18 months. So I had a strong sense that there was capacity there, as well as an unmet clinical need. “Once it was launched, the Research Targeting Tool enabled me be to back-up my intuition with hard evidence. I was able to visually demonstrate high incidence of respiratory conditions versus low levels of research in our region. It was the perfect conversation starter - a spark to ignite an interest and engage the respiratory clinical team in a discussion about bringing new research opportunities to our patients. “From that starting point we are now supporting the respiratory clinical team to learn more about research and we are working with our local NIHR Clinical Research Network team to identify relevant clinical studies that we hope to be able to offer to our respiratory patients in the coming months.” “The data is also invaluable in helping us to attract those studies. District General Hospitals often find it hard to compete with the bigger research centres yet, as the data

The app has the ability to compare up to four different maps at once. The example we normally use, and one that really illustrates the potential of the tool, is a map of diabetes research activity over the last three years alongside a map of diabetes disease prevalence. Immediately we can see that much of the research activity is focussed around large academic teaching centres centres such as Cambridge. However, the diabetes prevalence is actually quite low around Cambridge when compared to an area such as Bradford. So why Bradford? Well, add in a data set from the Office of National Statistics showing demographic indicators such as ethnicity and there is your answer; Bradford has a higher than average population of people from South Asian origin who are genetically more prone to diabetes. But what if the focus of your study is diabetes prevention? Then perhaps you’d find a heat map showing hot spots of childhood obesity at school year six more useful? It’s all there, in fact there are currently 32 datasets available, and we are working on adding more. Feedback so far tells us that the Research Targeting Tool has the potential to really help our partners in academia and the life science industry to place their studies intelligently. As a new addition to the NIHR Study Support Service, it certainly has become a conversation changer. We now have the ability to advise researchers how to plan their studies in areas where the patients exist and where the study has the best chance of successfully recruiting the required number of participants within planned timescales, while simultaneously meeting the clinical needs of the nation. www.nihr.ac.uk

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The baby brain scans that could help predict symptoms of autism and ADHD London researchers are embarking on a three-year study aiming to identify babies at higher than average risk of autism spectrum conditions (ASC) and attention deficit hyperactivity disorder (ADHD). The work at King’s College London is supported with funding of £199,968 from children’s charity Action Medical Research. Having one or both of these conditions makes life difficult for children and their families, and can seriously affect children’s education, employment chances and quality of life. The researchers hope that earlier information to help predict which children may go on to have difficulties with these conditions will open the door for support to be provided from infancy to those most in need, greatly helping children and their families. Both ASC and ADHD are common in childhood, as lead researcher Dr Tomoki Arichi says: “ASC is estimated to affect one per cent of children in the UK1, 2 and typically leads to impaired social interaction and communication. ADHD is more common, affecting up to five per cent of UK children1, 2 and is characterised by overactivity, impulsive behaviour and difficulties in paying attention.” It is already known that a family history of ASC or ADHD puts a child at a higher risk of developing these conditions. However it is still not known exactly what makes a baby vulnerable to later have these conditions. This has made it difficult to identify, develop and deliver interventions to those who need it most. There is now evidence that understanding the balance between two chemical messengers in the brain – known as neurotransmitters – called glutamate and GABA, may be key to unpicking what leads to altered brain development. Dr Arichi and his colleagues, physicist Dr Enrico De Vita and Professor of Translational Neuroscience Grainne McAlonan, are exploring the role of these two brain chemicals in shaping the developing brain.

Dr Arichi explains: “We want to see if a sophisticated scanning technique which measures the levels of these two particular neurotransmitters in the brain could allow earlier prediction of neurodevelopmental conditions in newborn babies known to be at risk.” The team will use Magnetic Resonance Imaging (MRI) scanners and a state-of-the-art method called magnetic resonance spectroscopy (MRS) which can measure the levels of chemicals in the living brain safely and precisely. They will measure glutamate and GABA levels in the brains of 80 newborn babies using an MRI scanner at St Thomas’ Hospital London with special adaptations and staff for scanning babies. They will also pioneer scanning babies on a new, highly powerful 7 Tesla MRI scanner which will be installed at St Thomas’ Hospital in the coming months. Dr Arichi explains: “Half the babies will be at high risk of developing a neurodevelopmental condition, due to an affected close family member, and half will have no increased risk – this group will be our control.” The researchers will compare results between the two groups to see if there are any differences. Studying equal numbers of high-risk babies and those at normal risk, they will: n use a state-of-the-art MRI technique to look inside the brains of 48 babies while they are asleep naturally. n look inside the brains of the other 32 babies using an even more powerful MRI scanner that can provide much more accurate data. Although there are no health risks from exposure to a strong magnetic field, the researchers will first carry out rigorous safety testing, as these will be the first-ever studies in newborns using this machine. The researchers will then carry out sophisticated data analyses to calculate the concentration of GABA and glutamate in the babies’ brains, and their ratios to each other and to other important brain chemicals. When the children reach two years of age, they will undergo a thorough neurodevelopmental assessment – and the researchers will then go back to interrogate their earlier

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Sam and Josh Lewsey and mum Cathy from Burgess Hill, West Sussex

scan data to look for alterations to these brain chemicals in babies who later develop difficulties. Commenting on the project Dr Arichi said: “We appointed a very experienced post-doctoral fellow in November – so we haven’t started any data collection yet but have just done some preliminary tests on the sequence with healthy adults.

ASC IS ESTIMATED TO AFFECT ONE PER CENT OF CHILDREN IN THE UK1, 2 AND TYPICALLY LEADS TO IMPAIRED SOCIAL INTERACTION AND COMMUNICATION.

“Although there have been studies which have tried to look at GABA levels in adults and older children with ASD, ours will be the first which will look at the levels of GABA and glutamate/glutamine in newborn babies at high risk of developing ASD. We hope that in doing so, we can understand how the condition might directly cause alterations in the levels of these neurotransmitters and alter how the brain develops – and crucially, before environmental effects (other illnesses, family, school, social deprivation etc) kick in and complicate things further. If we do find differences it will agree with what they have started to find in animals (but never before in humans), so it potentially has big implications for trying to develop treatments for ASD and then monitoring how they might influence neurotransmitter levels. “In addition to being the first study to collect this kind of data in newborn babies, we are planning to innovate on several technical levels as well – we will need to develop the MRI acquisition methods so that they can work optimally with babies and will also be scanning with a 7 Tesla MRI scanner (which has a much stronger magnetic field in comparison to the ones that are standard in the hospitals).” Dr Tracy Swinfield, Director of Research at Action Medical Research, comments: “We’re very pleased to support this

study. This research could lead to a new, safe, non-invasive technique to identify babies who may develop difficulties later in childhood, enabling early support and intervention where appropriate.” “Studying neurotransmitter levels in the brain in early life could also help to inform new treatment strategies for currently incurable conditions such as ASC,” adds Dr Swinfield. Cathy Lewsey, whose twin sons Sam and Josh were diagnosed with ASC aged six, knows from personal experience how important an early diagnosis can be. “When you have children with autism spectrum condition you can’t assume anything about family life. You simply have to tear up the rule book and start again,” she says. Sam and Josh, now aged 12, are identical twins. In many ways, they are just like other boys of their age, enjoying cub scouts and playing computer games like Minecraft and Skylanders. But they have a strong need for routine, find it hard to understand other people’s feelings and viewpoint, and their behaviour can be challenging. Sam and Josh had a remarkably calm start in life: despite being born at just over 34 weeks, they came home after only four days in hospital, weighing 5lbs 8.5 ounces and 5lbs 3.5 ounces respectively. “They ate, slept and rarely cried,” Cathy remembers. “They were the easiest babies ever.”

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The team working on the project, including those funded by Action: (from left to right) Judit Ciarrusta (PhD student); Rali Dimitrova (post-doctoral researcher);Jakki Brandon (clinical research nurse); Tomoki Arichi (paediatrician) Enrico De Vita (MR physicist); Elaine Green (radiographer); Grainne McAlonan (psychiatrist) It was only when the boys started pre-school that their difficulties became apparent. Cathy recalls: “Josh would have to be peeled off me and would then sit facing the wall, rocking. Sam would run for the back door and he’d be off up the road if no-one stopped him.” Fortunately, the nursery staff were, Cathy says, ‘absolutely amazing,’ gently expressing their growing concerns about little Josh and Sam and working hard to help them cope with the transition to primary school. But without a diagnosis that could explain the boys’ behavioural difficulties, Sam and Josh started Reception class with no formal support in place. And, sadly, things quickly became very difficult. Often upset and frustrated, Sam and Josh would scream, shout, lash out and throw things. “Josh spent most of the first 18 months sitting under the teacher’s desk,” Cathy recalls. “Even at just four or five years old, both boys were frequently excluded from school, sometimes every week.”

Teaching assistants were brought in to work with the boys on a one-to-one basis but they were, Cathy felt, babysitting rather than teaching the boys. “Sam and Josh do not have learning disabilities; in fact, they are now on the Gifted and Talented register for maths and science,” she points out. The boys were not diagnosed with ASC until they were six. After they moved to a small specialist school where teachers understand their needs, Sam and Josh thankfully started to thrive. They now attend a secondary school that is residential from Monday to Friday. “They are home every Wednesday night for scouts, which has been a fantastic outlet for Sam especially,” Cathy says. “Sam has made amazing friends from mainstream schools, who completely support, understand and encourage him. He has done things we never thought he would be able to do, like a 12-mile walk, a two-day camping trip and throwing a tomahawk!” As Sam and Josh grow up, it’s becoming apparent that sadly Josh has much more complex needs, and many challenges lie ahead.

“They were not allowed to join the other children at playtime, lunchtime or for sports,” Cathy adds. “The school said it was for their own safety and that of others, which of course we understood, but it was very upsetting.”

As Dr Arichi notes, neurodevelopmental conditions like ASC or ADHD have a long-term, wide-ranging impact on the lives of children and their families, making research into this area as important as it is rewarding.

“It was a time of utter desperation,” Cathy says. “Our parenting skills were openly called into question, even though we’d raised three other children. We just didn’t know what to do.”

1. National Institute for Health and Care Excellence, Clinical Knowledge Summaries: Autism in Children https://cks.nice.org.uk/autism-inchildren#!backgroundsub:2 2. Sayal, K., et al, ADHD in children and young people: prevalence, care pathways, and service provision. Lancet Psychiatry. 2018; 5(2): 175-186.

“We’re very pleased to support this study. This research could lead to a new, safe, non-invasive technique to identify babies who may develop difficulties later in childhood, enabling early support and intervention where appropriate.” Dr Tracy Swinfield, Director of Research at Action Medical Research 28

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Scientists find potential new way to target norovirus family Researchers have made a significant breakthrough in understanding how a family of viruses, including the norovirus, initiate infections.

the cell, allowing the virus to inject its genome into the host cell and begin the infection process.

The new study, published in Nature and led by the University of Glasgow, reveals the inner workings of the calicivirus family, which includes norovirus and sapoviruses – highly infectious viruses that can cause outbreaks of diarrhoea and vomiting.

Dr David Bhella, who led the research, said: “We have made a significant break-through in understanding how this family of viruses initiate infections. When viruses infect us, they bind to and then enter our cells. This is often by a process known as ‘endocytosis’, the process cells use to bring in nutrients from their environment.”

It is hoped this research may provide a new target for the development of antiviral drugs to prevent diseases like norovirus. Norovirus is highly contagious and can be very difficult to contain. Commonly outbreaks occur in hospitals, care homes, schools, hotels and on cruise ships. Caliciviruses are also important animal pathogens, causing ‘cat flu’ that can be associated with very high mortality rates in domestic cats. Using the Nobel prize-winning technique of Cryo-Electron Microscopy (CryoEM) researchers at the Medical Research Council University of Glasgow Centre for Virus Research studied the structure of the virus that causes ‘cat flu’ feline calicivirus. They made a significant breakthrough in understanding how this family of viruses initiate infections. They discovered that after binding to the cell surface, these viruses undergo structural changes leading to the formation of a portal – a funnel-shaped structure on the virus particle surface – which is thought to insert into the membrane of

This insight into the early stages of calicivirus infection provides a new target for the development of antiviral drugs to prevent this family of viruses.

Viruses trigger endocytosis, causing the cell to bring the virus particle (or virion) into the cell in a bubble or vesicle called an ‘endosome’. The virus then needs to break out of the endosome to release their genes into the cell and start the infection. Dr Bhella continued: “Furthermore, we have calculated an atomic model of the portal protein - known as VP2. While VP2 was known to be critical for the production of infectious virus, its function has been hitherto undetermined. “Our finding that VP2 assembles a portal that is likely responsible for endosome escape represents a major step forward in our understanding of both the Caliciviridae and icosahedral RNA containing viruses in general.” The paper ‘Calicivirus VP2 forms a portal to mediate endosome escape’ is published in Nature. The work was funded by the Medical Research Council (MRC) and the Biotechnology and Biological Sciences Research Council (BBSRC).

“We have made a significant break-through in understanding how this family of viruses initiate infections. When viruses infect us, they bind to and then enter our cells. This is often by a process known as ‘endocytosis’, the process cells use to bring in nutrients from their environment.” 29

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Considering a pharma and bioscience patent? The UK Intellectual Property Office maps out the application journey Lawrence Cullen & Laura Starrs Patent Examining Group Heads, IPO

Managing a patent portfolio requires, among many skills, the ability to anticipate the future. This is especially true in the fields of bioscience and pharma where, when drafting the patent, one must consider that the compound â&#x20AC;&#x201C; biological or chemical - that looks the most promising now may not be the one that gets approved for public use. In this article, we will consider the types of issues that a small start-up company may consider regarding when and where to file (or not file) a patent and the role of a national patent office such as UK Intellectual Property Office. A patent allows its owner to prevent others from being able to work on the same compounds or processes that you are interested in. However, in the field of bioscience and pharma the patent application comes at a very early stage of the development of the product, many years before

its efficacy and safety have been proven. Consequently, difficult decisions must be taken as to how broadly to draft the patent: too broad and the risk is the application is not capable of being granted, too narrow and you miss the key invention which needs protection. In the biological field, patents may relate to the properties that the protected compound would have, such as the presence of certain binding regions in an antibody capable of binding a specific antigen. In the small molecule area, it is common to use a general Markush structure to protect a family of compounds that all share the same structural properties. In both cases, the patent will have to include enough information to support what is claimed to have been invented. Working out how much evidence to include is a matter for the applicant working with their patent adviser. For a small start-up company or university spin-out in the bioscience area, a granted patent will often be an early sign of progress and one of the companyâ&#x20AC;&#x2122;s important assets. Sometimes such companies already have a significant investment from a larger company with the experience to manage clinical trials, other times the patent will be part of the process that the small spin-out/start-up uses to attract such inward investment. No matter what the situation, the value of the patent or patents in question is a key consideration and something that can be hard to quantify.

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Patent value can change over time, increasing in value as the results from clinical trials progress successfully through the various stages. It can also depend on the size of the market in which protection is sought. The patent landscape in Europe offers choice of systems to an applicant that provide patent protection at national level via the various national Intellectual Property legislation, such as the UK Patents Act 1977; at regional level via the European Patent Convention (EPC); and at international level via the Patent Cooperation Treaty (PCT). The choice of which system to use is driven by size of market, cost of obtaining and maintaining patent protection in that market and value of the invention to the applicant. The regional and international routes offer a more streamlined way of obtaining protection in many different countries more cheaply than applying to national IPOs in each country separately. Important considerations are to decide how many countries to seek protection in and how long to maintain that protection. For example, a new cancer treatment has a potential market all over the world while a vaccine to protect against a disease only found in specific climates may require protection in fewer countries. Companies in the biopharma and pharma fields are more likely to keep their patent in force for the full 20-year term. This reflects the length of time needed to obtain regulatory approval before the patent owner can start to exploit their invention and recover the significant costs of R&D. By contrast in faster changing technology areas such as telecommunications, an applicant may only pay renewal fees to keep a patent in force for 5-10 years. Costs can quickly escalate as an application progresses and those costs come at an early stage of product development before a company has any certainty that their new product has commercial value. This presents an interesting question for the spin-out/start up – do they apply for a patent via the PCT route that can provide protection in up to 130 countries and pay the associated fees in terms of processing fees and fees for professional advice to prepare and draft the patent? There is no guarantee that they will attract a licence. Companies can, however, make use of the steps in the system which allow for decisions to be taken in stages and so help manage costs. The first part of the process before the UK office, like many other national and regional offices, is to carry out a search to identify the most relevant published literature which describes aspects of the invention in the patent application. Making sure your invention is new and not obvious is the first step in obtaining a granted patent. An applicant can make an initial application for a search to a national office such as the UK IPO and ask for the patent to be searched. This search will take usually about 6 months and depending on the documents found the applicant can then decide if they want to take the application further. If they only require protection in one country then the option to proceed to the next stage of examination and (hopefully) grant with the same national office exists. At present in the UK the process from application to grant takes on average 5 years in the bioscience/pharma field, but given that the search at the IPO is nearly always the first step in the process, the IPO is working hard to ensure the results of this initial search are available in 6-7 months to ensure sufficient time to allow the applicant to decide what next – stop the application or proceed to the next stage! However, those interested in protection in a wider market, can use the national application as a priority application for another patent application concerning the same invention, adjusted to take account of the results of the earlier search, if necessary. That can be at a regional level – such as at the European Patent Office in Munich under the EPC, or at an international level via the PCT which is coordinated by

the Geneva, Switzerland based World Intellectual Property Organisation (WIPO). This allows access to a greater potential market and with a clearer idea of the potential for a granted patent. This is a more attractive investment possibility. The patent application made by the PCT route will enter what is known as the “national phase” or the “regional phase” after search at a time that can be selected by the applicant, that is 30 – 40 months after application date. This will require another input of funds for fees and handling. It is at this stage where a detailed examination of the application is made. This examination takes into account what was found in the search and determines whether the legal requirements for the grant of a valid patent have been met. The choice of regional phase or national phase will also depend on where and how much coverage and possibly also how quickly the applicant wants a granted patent. Working out how much all this activity will cost, when the cost will be incurred and how much has to be laid out before there is the possibility of receiving any investment will depend on the specific circumstances of each company and application. Deciding how many countries you want to have patent protection in is key. Is UK or Europe enough or do you need wider coverage including, for example, the Americas, Asia? In general, it is cheaper to use the regional and international routes as the number of countries in which protection is sought increases. For example, if protection is wanted in more than seven countries then the PCT route may be cheaper than applying to seven national offices individually. At the European level, that cross over point is around 5 countries. Official fees – such as those for handling at the UK Office, EPO or under the PCT - are only a part of the cost. Information about these and guidance on when they are incurred is available from most national patent offices1. While the use of professional advice can greatly improve the chances of gaining granted patents that provide a useful protection, such advice and knowledge comes at a cost. Some bioscience and pharma companies employ in-house patent experts to secure their continued progress and the development of their valuable IP assets. Thus, the applicant can obtain a patent valid in the UK via a number of routes that allow them to take into account the potential size and value of the market and what will be most likely to attract investment. While requiring a significant investment up front, the system does provide ways to stagger costs while gaining more information on the potential usefulness of the product(s) protected by the patent. After all, a patent will only be as good as the product it protects. www.gov.uk/government/publications/protecting-youruk-intellectual-property-abroad For Information on national, regional and international Patent Fees at the UK IPO see www.gov.uk/government/collections/patent-cooperation-treaty-pct-fees; with some guidance on their use at www.gov.uk/government/publications/protecting-your-uk-intellectualproperty-abroad www.gov.uk/government/publications/patent-cooperation-treaty-for-privateapplicants 1

www.gov.uk/request-uk-processing-of-international-patent-application

Intellectual Property Office is an operating name of the Patent Office

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How intellectual property can help 3D printing support, not harm, medtech 3D printing, or additive manufacturing, is frequently, and rightly, hailed as the next revolution in technology. Since its inception in 1986, 3D printing has transformed numerous sectors including aviation, manufacturing, and energy, and altered perceptions surrounding cost and timeefficiency in production. However, no-where has it demonstrated its far-reaching potential for beneficial industry, and societal advancement, more clearly than in the medical and medtech sectors. Dental implants, customised prosthetics, and hearing aids are among the life-changing artificial treatment devices which have been produced. While medical technology including in vitro diagnostics, and orthopaedic devices, have transformed the delivery of treatment. Previously, producing a customised medical device would have proved to be too costly and inefficient to be explored on a wider scale. However, thanks to the revolutionary capabilities of 3D printing, bespoke medtech devices can now be produced at a significantly lower cost with ease. But, with the growth of 3D printing and its capabilities within the medtech world, comes the inevitable intellectual property consideration. Vast sums of money, time, and research are invested annually into creating life-changing medical devices, and as such, these are thoroughly protected by robust intellectual property portfolios. However, with the ability to custom manufacture innovative products at the touch of a button, what are the IP implications for medtech manufacturers? Here Jim Robertson, a partner and patent attorney at leading intellectual property firm Wynne Jones IP explains why IP is crucial in ensuring 3D printing is supporting the growth of medtech, and not harming it. Mr Robertson, a specialist in protecting the medical devices, life science, and biotechnology fields, said: “IP is able to support the growth and success of 3D printing in a number of areas. “For example when it comes to new 3D printing devices, patents can protect the inner workings of the technology, including new and improved additive manufacturing processes through to the materials used in the processes, and data acquisition. “Critically, IP can protect the actual end-product itself - it is important to separate 3D printing as the manufacturing technology from the innovative end-product and how it is structured, functions and works and the technical problems that it solves. “So applied and executed correctly, IP can support both the growth of 3D printing and the technology it creates.” But where does the innovator behind a new 3D printed medical device begin when it comes to safeguarding their creation? “When an inventor files a patent application, they are then given the opportunity to get a granted patent, which can

provide them with a monopoly over the invention for up to 20 years,” he said. “In order to get a granted patent, an invention has to be new, and inventive. If, for example, an invention is made publicly available before a patent application has been filed, the invention will not be new and will not be patentable.” But what about 3D printing technology’s ability to potentially, and effortlessly, infringe on existing medtech? Mr Robertson said that in order for the medical industry to protect its interests and investments in a competitive environment such as this, they must establish a thorough intellectual property strategy, which considers technological advancements such as 3D printing. He said: “I believe a clear business strategy needs to be established and reviewed regularly, which plans for technical innovations in the industry. Once that is in place, it can drive the IP strategy, and address any strengths, weaknesses, opportunities, and threats. “Some businesses will have a key technology that they need to protect, and obtaining granted patents covering that technology may be critical when discussing the capabilities of 3D printing. This is particularly relevant when it comes to protecting the technology behind medtech. “Patents can also be used to prevent ‘work-arounds’ and make it difficult for other companies to compete against them. This will address any potential loopholes which may appear later in the patent’s lifecycle due to emerging technologies.” Wynne-Jones IP is a UK firm of intellectual property specialists, with offices in Cardiff, London, Cheltenham and Telford. Trading for over fifty years, the firm advises businesses and inventors in a wide range of sectors worldwide on all aspects of IP rights, strategy and renewals.

Your team for Life Sciences IP Is Life Sciences your field? When you need help with intellectual property rights, remember that we’ve been active in this field for decades. Whether you’re a lone inventor, SME or large corporation, you must identify and protect your Crown Jewels®. These are the core technologies, inventions or processes that are critical to your business strategy. We will work with you to fully understand the commercial and strategic needs of your business and take away the hassle and worry of IP.

What’s more we know our stuff in: Strategic IP management | Setting IP budgets | IP asset management | Funding for IP

What are you waiting for? Let’s talk Life Sciences. Jim Robertson, Life Sciences Team Leader T: 01242 267 600 E: jim.robertson@wynne-jones.com W: www.wynne-jones.com

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UK Supreme Court inflicts more patent pain on Warner-Lambert held that, while the disclosure of the patent supported claims referring to the treatment of inflammatory pain, it did not do so for any kind of neuropathic pain.

Eilidh Pugh,

Pharmaceutical Patent Attorney, AdamsonJones The UK Supreme Court has handed down its muchanticipated decision in WarnerLambert Company LLC v Generics (UK) Ltd t/a Mylan and Actavis. The case is important because it is the first time the Supreme Court has provided direction on two important issues: the role of “plausibility” in deciding whether an invention based on a new medical use is adequately disclosed in a patent, and how infringement of such a patent is to be assessed.

BACKGROUND The patent in question concerned the use of pregabalin for the treatment of pain. Pregabalin was already known for the treatment of other indications, so the claims of the patent are in the “Swiss” form, i.e. purpose-limited process claims: “Use of pregabalin for the preparation of a pharmaceutical composition for treating pain”. Actavis manufactures a generic pregabalin product that was suitable for treating pain but was not explicitly marketed for that use. The lower Courts held the patent to be invalid because the invention was not adequately disclosed, and the Supreme Court rejected Warner-Lambert’s appeal against that decision.

SUFFICIENCY AND THE PLAUSIBILITY TEST The majority of the judges took the view that a plausible disclosure of efficacy requires there to be technical information in the specification to show how the invention works for the uses covered by the claim. As a result, they

Their decision highlights the importance of including a technical rationale for any assertion of therapeutic efficacy in a patent application.

INFRINGEMENT The judges agreed that if the relevant claims had been valid, they would not have been infringed. However, their remarks on this topic were obiter and not binding, and there were considerable differences in their reasoning. Some considered the sole criterion for infringement of Swiss claims to be whether the product, including any labelling or accompanying leaflet, is presented as suitable for the new patented use. If not, there is no infringement. This appears to be good news for generics as it indicates that generic products which do not identify the patented use on their packaging or instructions (“skinny labelling”) would not infringe a Swiss claim in the UK. However, other judges felt the intention of the manufacturer should also be taken into account. Generics therefore cannot rely solely on skinny labelling just yet.

MORE TO COME This decision means that for a patentee it is important to include enough technical information in a patent for a new use of a known drug for that new use to be plausible. For a generic manufacturer seeking to avoid infringement, however, the position remains unclear: is skinny labelling sufficient, or is it necessary to make it clear that the generic product is not to be used for the patented use, or even to take active steps to prevent it being used in that way? Hopefully, definitive rulings on this point will be forthcoming soon. If you have any queries on this topic, please contact Eilidh Pugh at eilidh.pugh@adamson-jones.co.uk.

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Patent Protection of Medical Devices - Time for a Rethink? The duration of patent protection for medical devices is up to twenty years, as for any other type of device. Pharmaceuticals, on the other hand, may be entitled to an extended duration of patent protection. The justification for this is to allow an adequate return on investment following the time and cost for pharmaceuticals to be granted regulatory approval. The patent system is there, after all, to reward innovation not prevent it. This article examines the emerging grey area between medical devices and pharmaceuticals, and asks whether the current system is fair. Christopher Burnett,

Patent Attorney, AA Thornton There are two main ways of extending patent protection for a pharmaceutical - filing so-called “second medical use” applications, and obtaining a “Supplementary Protection Certificate” (SPC). As the name suggests, a second medical use application claims a new therapeutic use for a known pharmaceutical, whereas an SPC may extend the life of a patent directed to a new pharmaceutical by as many as five years (and a further 6 months for paediatric drugs). Increasingly, pharmaceuticals and devices are integrated, and nano and biosorbable device technologies blur the lines with pharmaceuticals, and all may require similarly lengthy and expensive regulatory approval. Attempts have been made to use existing legislation to protect these devices, but so far, these attempts have largely been unsuccessful.

SECOND MEDICAL USE CLAIMS Patents directed to therapeutic methods are excluded from patentability in Europe and many other countries, so as not to restrict the freedom of medical practitioners. There is an exception for a new therapeutic use of a “substance or composition”, even if already known. The term “substance or composition” has been defined in case law as the active material that achieves the therapeutic effect in a treatment. Attempts have been made to define medical devices to fall within the above definition, but it has proven difficult. A very recent case related to a filler material that is injected between tissues prior to radiation therapy in order to reduce radiation exposure of secondary tissues. The filler was a known material, but the medical technique was new. It was decided that the therapeutic effect was achieved by physical displacement of the sensitive tissue and not due to the chemical composition of the filler. The spacing effects were present for any filler material, which further underlined that the effect was physical and independent of the filler’s particular chemistry. It was thus concluded that the filler was a device and not a substance or composition, and the patent was denied.

As “substance or composition” can be summarized as a product that achieves a direct therapeutic effect by a chemical, as opposed to physical, interaction with the body, it is still possible to protect non-pharmaceutical devices and substances which are effective by nature of their chemistry, for example a surgical dye for use in eye lenses. Furthermore, protecting the new use of a pharmaceutical, where the new use requires a particular device, may be possible.

SUPPLEMENTARY PROTECTION CERTIFICATES SPCs are not available for standalone medical devices, but could potentially be available for device-drug combinations. However, recent case law makes this unlikely. In order to get an SPC, you need both a patent and a marketing authorisation. Whether or not you get a marketing authorisation depends if the drug-device combination is regulated through the Medicinal Products Directive (MPD) or the Medical Devices Directive (MDD). Marketing authorisations are sought through the MPD and are explicitly entitled to be used for the purposes of obtaining an SPC, however regulatory approval obtained by the MDD are not. It was recently held that Boston Scientific, whose patented coronary stent released a sustained dosage of cytochalasins (approved under the MDD), was not entitled to an SPC even though assessment under the MDD was equally as arduous as that of the MPD. The intention, and interpretation, of the law was to permit extra protection for pharmaceuticals to protect investment in view of the regulatory hurdles. This however seems to unfairly penalise those who operate on the boundary between devices and pharmaceuticals, who face the same time and cost challenges, and is therefore something that needs to be reconsidered. If you have any queries regarding this topic, or other pharmaceutical or biotechnological matters, please contact Chris at cjb@aathornton.com or visit our website aathornton.com

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Making clinical trials right for older people In this issue, we speak to Miles Witham, Professor of Trials for Older People at Newcastle University and consultant geriatrician, about why he’s bringing about a sea change in how clinical trials involving older people are designed and carried out. Miles works in the NIHR Newcastle Biomedical Research Centre (BRC) which specialises in translational research relating to ageing syndromes and long-term conditions, drawing on the University’s longstanding expertise in this area. Improving the physical function and quality of life for older people is at the heart of his work, but in order to achieve this, trials need to be designed appropriately to test interventions targeted at syndromes associated with ageing. “My role is about designing trials that are right for older people and which are easy for them to take part in. There is not much research on how to do this – so part of our work is about building up the methodology evidence base on how to design successful trials for older people,” explains Miles. It is timely work, for figures from the Office of National Statistics, show the UK’s population is getting older, with 18% of the population aged 65 and over and 2.4% aged 85 and over – with these percentages set to increase over the coming years. Yet until recently, there was little research on how best to treat older people. “In practice, older people haven’t been included in clinical trials – so we don’t have evidence of whether the findings apply to them,” explains Miles, “Given older people make up an increasing percentage of the population, it’s all the more important we find the treatments which work best for older people. “We need to ensure the trials we’re conducting are right for the people we look after in the NHS these days. The population is ageing and few older people have only a single condition – increasingly people have multiple conditions or multimorbidity – yet traditionally research hasn’t taken this into account.” “Trial findings tend to be based on results from people with a single condition, and applying those findings to someone with multimorbidity doesn’t always work. The findings can be misleading and are not necessarily right for the people we see in the clinic. If we are going to give the right advice to older people so that they can make decisions about their healthcare, we need to ensure that we properly understand the balance of benefits and risks that a treatment has for older people. With this in mind, Miles is working to improve the way that trials are designed and run, facilitating the participation of older people and building capacity across the UK to conduct trials specifically for older people.

“Running trials for older people is difficult – it’s something that academia and pharmaceutical companies have stayed away from because of the complexities and challenges involved. “Trials for older people take more effort and they take longer. You need to recruit more people, as more adverse events happen and more people drop out, in addition, you’ll find that the population is not so homogenous as people grow older. As researchers, we need to embrace that complexity, it isn’t going to go away, we have to accept it as part of the package. Instead, we need to accept that we will need larger sample sizes and to ensure trials are adequately funded to support a larger sample size. “A particular skill set is needed to help older people take part in clinical trials. Older people need time and space to think about their participation and an opportunity to discuss it with other people, in addition, their priorities tend to be different from those on which most clinical trials are based. “The focus of many clinical trials is on whether you are dying or not – yet for most older people it is quality of life and physical function that matter most. It’s important we let patients’ voices be heard in designing our research projects and continue to listen to them throughout the research – so we produce findings relevant to them. Research should be about what’s right for the patient – not what’s right for the researcher. “One of the challenges is looking in the right places for people to participate in our research and that’s not in hospitals, which are often not the most representative places to conduct research. Researchers need to reach out to the broader community - where, for example, are homeless people in our research? How do we ensure that those who don’t speak English are included? “We’ve worked closely with GP’s and other primary carers in identifying and contacting older people suitable for studies – the community is where most older people live, so that’s where we should be doing our research. Until recently, care homes were neglected, but colleagues across the UK have been putting structures in place to engage with them too. We know that units that do research provide better care, so it’s a good thing for both residents and staff. “Colleagues have also worked with libraries, sheltered accommodation and football clubs, amongst others. When I worked in Scotland, we knew that thousands of retired people played bowls – so we contacted local bowls club to

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recruit people to our studies. As researchers, we need to be more creative in how we contact potential participants.”

the condition, even though it’s estimated to affect around one in ten people over the age of 75.

“Regulators have a role too. If pharmaceutical companies want to produce and market medications for older people with multiple conditions, we need to make it a condition of marketing approval that they’ve conducted trials that involve older people with multiple conditions.”

Another of Professor Witham’s trials is examining the use of sodium bicarbonate to treat high acid levels in older people with advanced kidney disease, a treatment which has long been used but for which there is little supporting evidence. The study has deliberately targeted older people with chronic kidney disease, who’ve been neglected in previous studies, with the aim of establishing whether or not this accepted treatment works. We await the results with interest.

One study underway that’s embraced older people is the LACE Trial into sarcopenia, the loss of muscle size and strength that happens as we age. This medical research study for people aged 70 years old and over who have muscle weakness is examining whether Leucine and ACE inhibitors can act as therapies to improve muscle size and strength. Trials such as this represent a major breakthrough. Sarcopenia has only recently been given an ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) code, so few studies have looked at

“Running trials for older people is difficult – it’s something that academia and pharmaceutical companies have stayed away from because of the complexities and challenges involved.” 37

Organ specialists, Miles explains, have an important role to play in recruiting older people to clinical trials. Nowhere is this more evident than in the area of cardiology. A British Heart Foundation funded study (the SENIOR-RITA trial), led by Newcastle, is examining whether current UK practices for treating heart attack patients are the most suitable treatment for those aged over 75. This is all the more important when you realise that over 50% of heart attacks happen in patients aged 75 and over and many have other health problems too. “These research projects are good examples of what we need to do in order to engage more people in clinical trials and ensure the outcomes are relevant for our patients. All in all, we need to realign our recruitment and research structures so they are where people are and ensure the research we’re doing is relevant to the target group. “Making it easier for older people to take part in and stay in our clinical trials is crucial if we are to generate better outcomes from our research.”

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Bringing patients and providers together one tweet at a time As an open forum for human interaction, SOCIAL MEDIA PROVIDE PATIENTS AND CAREGIVERS WITH EMOTIONAL SUPPORT social media have become the great equalizer A 2012 survey from the PricewaterhouseCoopers (PwC) of health information – providing a means for Health Research Institute found that one-third of people patients and health care providers to connect actively use social media for health-related matters, with outside of the hospital or local clinic setting and 25% having posted about their health experience online and learn from one another. 20% having joined No longer a static “read-only Web,” the Internet provides a space for dynamic interactions between users. Individuals can create, post, and share content relevant to them through individual and collective blogs (e.g. the Mighty); microblogs (e.g. Twitter); social networking sites (e.g., Facebook, LinkedIn, Inspire, and Patients Like Me); video, podcasts, and other file-sharing platforms (e.g. YouTube); e-gaming; and wikis. For health care consumers – patients and caregivers – this new, participatory Internet set the stage for a health revolution. Over the last decade, the interaction-driven landscape of Web 2.0 has changed how health and health care are understood and navigated. Able to obtain and share health information, engage with clinicians and health care institutions, and, importantly, connect with others with similar illness experiences, patients and caregivers now have the tools to be more informed, connected, and proactive health care consumers than ever before.] But patients and caregivers aren’t the only ones benefiting from an interactive, and highly social, Internet. Up to 65% of researchers and health care providers are estimated to actively use social media for professional purposes, such as social networking, professional development, and coverage of medical meetings. It’s now common practice for meetings and courses to have their own hashtag, and many have relaxed rules against photography to facilitate slide-sharing on social media. It has even been suggested that within then next decade, medical professionals will not be able to be successful scholars without some activity on social media. This widespread adoption of social media truly marks a redefinition of how patients and providers obtain information and make connections in the information era. While many providers readily recognize the value of social media in augmenting their professional activities, far fewer are comfortable using social media to interact with the patient community. Concerns about the spread of medical misinformation, breaches of professional boundaries, and risks to patient-sensitive information dominate the debate. These concerns have even led to the establishment of guidelines on social media use by health care institutions and professional societies, including the American Medical Association (AMA) and the American College of Physicians and the Federation of State Medical Boards (ACP-FSMB). But despite concerns of misuse, social media can improve how medical care is performed and received, offering new opportunities for both patients and providers to connect and learn. While the potential benefits of social media in health care are many, the following are a selection of examples of how social media can enhance patient-provider communication, give voice to the patient perspective, and, ultimately, lead to better outcomes.

a health forum or online community. Adding to this, the Health Online 2013 research survey from Pew Research Center’s Internet and American Life Project found that among those looking for health information online in the last year, 18% actively searched for others who might share the same health concerns and 26% read or watched someone else’s account of their health experiences or medical issues on social media. At that time, 60% of Americans regularly used some type of social media. Since then, that percentage has risen to 69% of the population, and reflects, among other factors, the growing adoption of social media by older adults. Having stable social support has long been understood to improve health outcomes for patients. But, for those affected by a chronic illness, the ability to share illness-related experiences with others who face similar challenges online offers additional benefits. While 18% of the population have searched online for others who might have similar health concerns, this percentage goes up to 23% for Internet users living with a chronic illness or rare disease. With social media, patients are no longer constrained by their localized community but can connect with others around the world, establishing meaningful relationships, sharing information and advice, and building communities of support. These benefits have been found to be particularly important among those with poorer health status, those who experience illness stigmatization or trivialization, and/or those who are isolated or disconnected from traditional support. Social media offer new ways to build social networks, connecting patients and caregivers with others with similar illness experiences and fostering emotional support.

SOCIAL MEDIA LEAD TO MORE EQUAL COMMUNICATION BETWEEN PATIENTS AND PROVIDERS Not so long ago, the divide between the health care provider and the health care seeker was absolute – fixed in place and enforced by the localized office visit.

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But social media are changing this.

struggles and learn from us. Both parties would benefit.”

By literally taking away the walls of the patient-provider interaction, social media have changed how patients and providers communicate and relate to one another, upending the traditional patient-provider dynamic and empowering patients to take a more active role in their care.

Gastroparesis is a chronic digestive condition characterized by the presence of symptoms that persist or reoccur long-term together with slowed emptying of the stomach. While up to five million people are estimated to live with gastroparesis in the United States, the condition remains little-known, and those affected often face significant diagnostic delays.

A recent review of over 1,000 journal articles on the use of social media by patients for health-related reasons found that social media use by patients can lead to more equal communication between patients and providers – an outcome stemming from a heightened feeling of confidence on the part of the patient regarding his or her relationship with their provider. By increasing patients’ confidence in how they communicate with their providers, social media democratizes the decision-making process, empowering patients to become involved in key decisions relating to their care. This may even serve to encourage patient adherence to their treatment plans, improve patient satisfaction with the care they receive , and increase patient willingness to seek medical attention.

SOCIAL MEDIA HELP PROVIDERS BETTER UNDERSTAND THE PATIENT PERSPECTIVE Clinical research has not only become more patient-centered, it’s become increasingly patientdriven. The experiences and perspectives of patients and caregivers are playing an increasingly central role in informing and shaping research aims and practices. This is evident in the implementation of patientreported outcome (PRO) measures in clinical trials and increasing efforts to engage patients and caregivers in study design, drug approval, and health policy decisions. This is also true in clinical practice. Insights gathered from patients and caregivers have been used to make hospitals and other centers of care more patient-friendly, identify and address disparities in access to care, and shape the patientprovider interaction. While the available literature on the role of social media in promoting information-sharing in health care addresses patient-to-patient, provider-to-provider, and providerto-patient learning, notably absent is the potential for the transmission of information from patients to providers. Health care professionals and institutions can learn a lot from patients and caregivers. And, social media can help facilitate this learning. Patient and caregiver accounts of their illness-related experiences and needs on social media can help providers and health care institutions better understand their patients and use this knowledge to develop solutions that improve outcomes. As gastroparesis patient advocate @melissarvh tweeted, “It’s (patient presence on social media) underutilized by researchers, medical professionals, pharma, & others. We are a significant resource & you all are thinking too small by dismissing our value to you. 20,000 patients in my #Gastroparesis group, all waiting to be heard.” She goes on to tweet, “Those involved w/ our care need to see our

In recognition of Gastroparesis Awareness Month 2018, the International Foundation for Gastrointestinal Disorders (IFFGD), a patient-driven non-profit education and research organization, launched a campaign on Twitter to raise awareness and elevate the experiences and needs of patients and caregivers using #HearMeGP. During August, patients and caregivers, other patient organizations and professional societies, treatment manufacturers and e-health companies, professional journals, health care institutions, and providers all tweeted with #HearMeGP. Participants shared facts about gastroparesis, videos and blogs documenting their personal experiences with the disease, messages of support and encouragement, and held discussions about their hopes for the future of gastroparesis treatment and care. The campaign reached almost 300,000 accounts and earned more than one million impressions. As a gathering place for people who share similar illness experiences, social media can help give voice to the suffering experienced by patients. Patients are coming together to share their lived experiences and needs. As a wellspring of patient insights into the experience of disease, social media can help providers and health care institutions understand the unmet needs of chronic illness patients and their caregivers and work towards solutions. #HearMeGP, and campaigns like it, illustrate how patients and caregivers, providers, and others, can come together on social media to make their perspectives heard and build a connected and informed stakeholder community. While social media hold certain pitfalls, their ability to bridge traditional divides in medicine and encourage information-sharing between patients and providers has changed the understanding and delivery of health and health care. Access to new avenues of information and support has emboldened patients and caregivers to take charge of their own care and wellbeing, working in partnership with their providers. And, in addition to offering opportunities to connect with other health care professionals, patient demands on social media to be heard are challenging providers and health care institutions to improve how they engage with patients both online and in person. In the end, we get a more informed and connected community of patients and providers learning from each other, strengthening relationships, and ultimately, improving outcomes. As concluded by Wald et al. (2007), “Collaborative teamwork between physician and patient might just lead to a genuine partnership, improving the quality of health care and engendering a more trusting physician-patient relationship. Might be worth a try.”

ABOUT THE IFFGD The International Foundation for Gastrointestinal Disorders (IFFGD) is a registered 501(c)(3) nonprofit education and research organization dedicated to improving the lives of people affected by chronic gastrointestinal (GI) illnesses. Founded in 1991, IFFGD helps improve patient outcomes by enhancing awareness, improving education, and supporting and encouraging research into treatments and cures for chronic GI disorders. iffgd.org

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Adult Vaccination “Vaccination can provide cost-effective protection against a host of diseases throughout life, but remains an underused public-health strategy in adults for the promotion of healthy ageing. Without specific vaccination programmes for the adult population aged >50 years infectious diseases will continue to be a cause of substantial morbidity and mortality in late adulthood.”1 Over the past 20 years we have seen the introduction of new vaccinations targeted explicitly at diseases which have a heavy burden on older adults including flu, pneumococcal disease and shingles, Yet despite these developments, it remains that for too many adults, immunisation is seen as being ‘just for kids’; a few jabs for toddlers and school children and a begrudged necessity when travelling to certain parts of the world.

The Spanish Flu wasn’t a one off. Since 1918 the world has witnessed three other flu pandemics. Asian Flu in the late 1950s killed 1 million people5 and the 1968 Hong Kong Flu infected an estimated half a million people. The 2009 H1N1 Pandemic6 saw between 150,000 and half a million deaths across the world. Yet despite the obvious risks of a future pandemic, academics and policymakers are concerned about growing complacency about the risks of infectious diseases7. Such complacency is misplaced. In the US, the flu continues to kill between 3,000 and 49,0008 people per year. In 2014/2015 the flu was blamed for an increase in winter mortality among older people in the UK9. There are fears that the world may be on the brink of another infectious disease pandemic. Late last year, the Daily Mail ran a story claiming “A global pandemic of a flu-like virus could kill 900 million people if it started to spread tomorrow”.10

HAVE WE FORGOTTEN THE LESSONS OF THE SPANISH FLU?

Climate change, global conflict, and increasing levels of migration11 and global travel increase the risk of diseases developing and spreading around the world very quickly. At the same time, humans are increasingly encroaching onto new environments, bringing together domestic and farmed animals closer to other wildlife.

Last year marked the 100th Anniversary of Spanish Flu. The deadly influenza (flu) pandemic infected some 500 million people2 and resulted in deaths of between 50 and 100 million people. 17 million people may have died in India3 and half a million Americans lost their lives. Spanish Flu probably killed more people than the Black Death and more people in 24 weeks than AIDS did in 24 years4.

In some those places most at risk of infectious diseases, there is an inadequate supply of healthcare workers12 to limit the spread of disease. There are also fears that that antibiotic and antiviral resistance may reduce our ability to recover from disease. The potential for information about disease to travel around the world quickly could spread significant fear and have major economic repercussions.

It is not viewed as the one aspect of a healthy lifestyle which doesn’t require us to abstain from a vice, work up a sweat or check a label for a food’s fat and calorie content.

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HOW CAN ADULT VACCINATION HELP? ILC-UK believes that vaccination has an instrumental role to play in reducing infection across the world. In November 2013, SAATI (Supporting Active Ageing Through Immunisation)13 published ‘Adult vaccination: a key component of healthy ageing. Benefits of life-course immunisation in Europe’ (SAATI, 2013), which put forward evidence that adult immunisation programmes, especially for those aged above 50, can bring significant health and socio-economic benefits.

References 1

Michel, J. -P., Gusmano, M., Blank, P.R. and Philp, Ian (2010) Vaccination and healthy ageing : how to make life-course vaccination a successful public health strategy. European Geriatric Medicine, Vol.1 (No.3). pp. 155-165.doi:10.1016/j.eurger.2010.03.013

2 https://www.ncbi.nlm.nih.gov/pmc/articles/

PMC3291398/ 3 https://www.geni.com/projects/1918-lnfluenza-

Pandemic-India-Fatalities/24256 4 https://www.nytimes.com/2004/03/14/books/virus-

alert.html

There is increasing interest and awareness in healthy ageing. As of August 2015 at least 5.5 million people in the UK had an active subscription to a gym14, with monthly prices ranging as widely as from £15 per month, or £180 a year, to up to £100 per month, or £1200 a year15.

5 https://en.wikipedia.org/wiki/1968_flu_pandemic 6 https://www.cdc.gov/flu/pandemic-resources/basics/

past-pandemics.html 7 https://www.gatesnotes.com/Health/Shattuck-Lecture 8 https://www.scientificamerican.com/article/how-

does-the-flu-actually-kill-people/ 9 https://www.theguardian.com/society/2015/

nov/25/excess-winter-deaths-rose-morethan-150-43900-2014

As well as purchasing new gym wear and any additional paraphernalia, in 2012 UK consumers spent £385 million on vitamins, minerals and dietary supplements16, all money spent in the pursuit of good health and fitness.

10 https://www.dailymail.co.uk/health/article-6006655/

A-deadly-virus-pandemic-kill-900-million-peoplehappened-today.html 11 https://edition.cnn.com/2017/04/03/health/pandemic-

risk-virus-bacteria/index.html

Evidence from the UK showed that during the 2014-2015 seasonal influenza season in the UK, only 50%17 of those aged six months to under 65 years in an at risk category received their free flu jab, a tried and tested method of keeping us healthy which requires no more exertion then popping to our GPs or booking a visit to a community pharmacy. For frontline health care workers, this figure was only 54.9%18.

12 https://ysjournal.com/the-critical-shortage-of-

healthcare-workers-in-sub-saharan-africa-acomprehensive-review/ 13

SAATI Partnership (2013). Adult vaccination: a key component of healthy ageing. Benefits of life-course immunisation in Europe. [pdf] SAATI Partnership. Available at: http://www.ilcuk.org.uk/ index.php/publications/publication_details/adult_ vaccination_a_key_component_of_healthy_ageing [Accessed on 22 January 2014].

14 https://www.theguardian.com/lifeandstyle/2015/

aug/18/uk-gym-membership-spending-up-by-44per-cent

Recent research by ILC-UK has highlighted how flu vaccination uptake has been falling across Europe.

15 https://www.theguardian.com/money/2014/jan/04/

buyers-guide-gym-membership 16 https://store.mintel.com/vitamins-and-supplements-

uk-september-2012?cookie_test=true 17 https://assets.publishing.service.gov.uk/government/

SO WHAT NEXT?

uploads/system/uploads/attachment_data/ file/429612/Seasonal_Flu_GP_Patient_Groups_ Annual_Report_2014_15.pdf

It is clear to us that adult vaccination is a key component of healthy ageing. Yet we are not maximising the potential of this intervention. In our ageing world it is vital that policymakers, consumer groups and industry work together to raise awareness and increase uptake of adult vaccinations.

18 https://assets.publishing.service.gov.uk/government/

uploads/system/uploads/attachment_data/ file/429612/Seasonal_Flu_GP_Patient_Groups_ Annual_Report_2014_15.pdf

ILC-UK intend to build on our work in this area an engage policymakers and practitioners in identifying solutions to the concerns we have highlighted. ilcuk.org.uk

| finance and funding |

| BIOSCIENCE TODAY |

Investment at the beating

heart The life sciences industry represents one of the most successful economic sectors in the UK and its growth is an important part of the government’s Industrial Strategy. An ageing population, a growing middle class and the increased burden of chronic disease means the global life sciences industry is expected to continue to grow at a rapid pace.

Accessing ECG monitoring at home, every day, for medical monitoring outside a clinical setting – with the potential to save valuable time and resources for the healthcare sector

If Britain is to keep up and maintain its reputation as one of the best places in the world to start and grow a business, then it is critical that we continue to invest in bioscience and research.

Enabling workers to demonstrate who they are, where they are and how they are – bringing improvements in worker verification, security and wellbeing

The life sciences sector employs over 230,000 scientists and staff across the UK and generates £64bn of turnover in the UK. Through its Life Sciences Sector Deal – part of the modern Industrial Strategy – the Government is aiming to ensuring the right infrastructure is in place to support the growth of life sciences clusters and networks. And crucially, we need to ensure smaller companies in the fields of bioscience and research have access to the start-up and scale-up funding to create more mature enterprises that can prosper and grow. A great example of such a business is Belfast-based B-Secur, which is pioneering next-generation biometrics using the heart to secure health and wellness insights in the connected world. Their HeartKey® technology captures users’ ECG signals using small and seamless sensors within smart clothing, wearables, or physical touch points. The resulting signal patterns, processed by complex algorithms, provide insights on the individual – from confirming who they to how they are feeling. Applications include: Accurately identifying who is at the wheel of a vehicle, and their state, at any time – improving motoring safety and reducing the risks of accidents

As an early stage company, the nature of the business required heavy R&D investment and, starting with private equity, they have progressed to include UK institutional Venture Capital investment. This has been a difficult process, and the company has had to deal with plenty of rejection along the way. As Alan Foreman, their CEO, admits, attitudes to risk, patient capital and debt capital can be more challenging in the UK, and particularly outside of London, compared to Silicon Valley. However, with perseverance and introductions through institutions such as British Business Bank, the business has found investors that understand its value and are helping B-Secur to compete on the global stage. B-Secur has grown to more than 35 people in four years, developing truly ground-breaking technology and introducing it to the world. B-Secur is a success story, having identified and secured the finance it needed for growth. Unfortunately, many potentially high-growth businesses simply are not aware of the full range of options available to them. In fact, according to polling carried out on behalf of the British Business Bank last year, a third of businesses in the UK are actively looking to grow this year but have no idea how to achieve this.

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| finance and funding |

Bioscience and other innovative SMEs are not only concentrated in London and the South East. There are important bioscience clusters in Daresbury, Manchester and elsewhere around the country, so it is important to address the significant imbalances in access to finance for smaller businesses across the UK both in terms of supply of capital and in raising awareness of the finance options available. In the last six months we have been ramping up our activity ‘on ground’ to enable pioneering regionally-based businesses like B-Secur to grow and prosper. An important development is our new UK Network, with managers based within each of the English regions and the three Devolved Nations. The Network, which was originally announced as part of the Government’s modern Industrial Strategy in November 2017, has a remit to identify and help reduce geographical imbalances in access to finance for smaller businesses across the UK. The specific role of the managers in each region is threefold: 1. Increase small businesses’ awareness and understanding of the finance options best suited to their needs; 2. Develop a deep understanding of the business finance ecosystems in all parts of the UK, so that the British Business Bank can improve its support to smaller businesses across the country; and 3. Add value to the business finance ecosystems across the UK by enhancing collaboration and co-ordination within and across each English region and Devolved Nation. These managers will work closely with business finance stakeholders and partners in their areas, acting as the ‘glue’ to improve the understanding and awareness of smaller businesses of the financing options available to them. We also have a number of supply-side finance interventions to increase the supply and diversity of finance in the regions and thereby support innovative businesses.

As the UK Government’s economic development bank, we want to change this by improving smaller businesses’ understanding of their finance options. When we make better information available to smaller businesses, we help them make better choices about finance - being more aware of and having more confidence in their options means businesses are more likely to seek funding, driving demand and growth. That’s why the Bank has launched the Finance Hub – a new interactive website, developed with a range of industry partners and business groups, dedicated to providing independent information on finance options for scale-up, high growth and potential high growth businesses to help them see what’s really possible. The Hub provides independent and impartial information on finance options and includes a simple six-step ‘Finance Finder’ that helps smaller businesses explore the finance options that could work best for them. The new site also features case studies and learnings from real businesses to guide businesses through the process of applying for growth finance. We also continue to work with the industry to provide clear information through resources such as our Business Finance Guide, which we developed with the ICAEW and 21 leading business organisations. Available from the Bank in hardcopy and as an online tool, it allows small businesses to easily navigate the range of finance options available.

Our UK Business Angels Market Report, published last year in partnership with the UK Business Angels Association, found that 57% of business angels are based in London and the South East. To enable businesses in other regions of the country to have greater access to early stage equity finance that can often play a critical role in supporting growth ambitions, we launched a new Regional Angels Programme in October 2018, which aims to develop regional angel clusters across the UK. Moreover, our regional funds, the Northern Powerhouse Investment Fund, Midlands Engine Investment Fund and Cornwall & Isles of Scilly Investment Fund, are helping reduce the UK’s regional imbalances in smaller business finance by supporting debt and equity finance to SMEs across their respective regions. These programmes - alongside our tools and guides to build confidence in and awareness of finance options - mean we will be able to help more regionally-based bioscience businesses such as B-Secur to identify and secure the right kind of investment, at the right time, to grow and prosper. If you are not clear on the full range of finance options available to your small business, you can learn about the many choices available at www.thebusinessfinanceguide. co.uk/bbb or follow the guide on Facebook @ TheBusinessFinanceGuide. If you are a business looking to grow rapidly, you can access our new Finance Hub at www.british-business-bank.co.uk/finance-hub

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An insight into the Cambridge economy – what lies ahead for Silicon Fen? Dr Andy Cosh Dr Giorgio Caselli

Centre for Business Research University of Cambridge

These are rather frantic days for the UK, since several outcomes remain possible following the Brexit referendum in June 2016. While the government strives to reach a deal with the EU before the UK’s departure on 29 March 2019, recent analysis from the Treasury suggests that Brexit is likely to make the UK worse off. In 15 years’ time, the national economy could be up to 3.9% smaller under Theresa May’s plan compared to today’s arrangements, with this figure increasing to 9.3% in a no-deal scenario. These results spark questions about the implications that this changing context may have for an economy like Cambridge, where companies rely on highly skilled labour and export heavily to other EU countries.

over time, are being used to inform the Local Industrial Strategy after the ground-breaking Cambridgeshire and Peterborough Independent Economic Review (CPIER). At the last count, the remarkable growth that we had revealed for 2015-16 was found to continue in 2016-17, despite the Brexit vote early that year. Global employment of Cambridge-based companies grew by 9.6% to 224,762 compared with a year earlier, while their global turnover went up by 14.7% to £43.3bn. During the period between 2010-11 and 2016-17, companies based in the Cambridge area witnessed a growth rate in employment of 6.9% per annum (9.1% in turnover). These figures indicate that the local economy has performed well over recent years, growing at faster rates than official statistics suggest.

Our work at the Centre for Business Research makes us well positioned to shed light on these questions. Since the project group’s formation in late 2014, we have been concerned with establishing an accurate and accessible source of information on the scale, make-up and growth rate of economic activity in the sub-region, defined as a 20mile radius around the city of Cambridge.

Among the key drivers of this growth is a thriving knowledge-intensive (KI) economy, which accounts for 26.7% of employment and 32.1% of turnover in the Cambridge sub-region. The 440 companies in the life science sector employed over 14,000 people in 2016-17, up by 8.2% from April 2016. Similar growth was also observed in the Information and Communication Technology (ICT) sector, with its 3,000 companies reaching a combined employment just below 20,000 people. Contributing further to a vibrant local economy are a variety of world-leading research institutions, including the Wellcome Trust Sanger Institute, the MRC Laboratory of Molecular Biology and the Babraham Institute.

The Cluster Map, which originated from the earlier platform launched in July 2016, monitors global employment and turnover of almost 25,000 Cambridge-based companies. The database behind the map, which is managed by the authors on behalf of Cambridge Ahead, has also been extended to cover the whole Greater Cambridge Greater Peterborough Local Enterprise Partnership (GCGP LEP), providing seven years of data for more than 70,000 companies. These data, which show the location of employment and its changes

These companies and research institutions are found to be clustered in and around Cambridge, following a process known as ‘agglomeration’. A case in point is the life science sector, which has experienced increasing density of similar organisations over time. While companies and research institutions operating in the life sciences tend to be located in the south and south-east of the city, ICT companies are concentrated primarily in the northern part of the city around the science parks.

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Collectively, companies operating in the life science and ICT sectors are estimated to have carried out over £2bn of R&D expenditure in 2016-17, far more than all other companies in the sub-region taken together. Furthermore, our survey of the largest players in the area indicates that these companies would not consider relocating their activity elsewhere in the UK, highlighting the additional benefits brought by the Cambridge cluster to the national economy.

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2012-13

Our company data provide clear evidence of the ongoing success of the ‘Cambridge Phenomenon’, a term first coined by Peta Levi in a Financial Times article to describe the explosion of hightech businesses in and around the city since 1960. The emergence of the Silicon Fen – as the area is often dubbed by analogy with Silicon Valley in the US – can be traced back to the founding of Cambridge Consultants, the brainchild of three Cambridge University graduates whose mission was to “put the brains of Cambridge University at the disposal of the problems of British industry”. The area has since grown to become one of the leading technology clusters in the world and is now home to over 30 science parks, including the Cambridge Biomedical Campus – Europe’s largest healthcare and medical research centre. Cambridge has also produced some of the UK’s most successful businesses and start-ups. Among the best known are Abcam, CMR Surgical and Kymab in the life science sector, along with ARM, Darktrace and Raspberry Pi in the ICT sector. The past few years have also seen the cluster quickly becoming a hub for artificial intelligence (AI) companies, with Fetch.AI, FiveAI and PROWLER. io all based locally. Alongside these homegrown companies, a number of international tech giants have established a presence in Cambridge, including Amazon, Apple and Microsoft in the CB1 development area. Therefore, it comes as little surprise that – according to an analysis by research consultancy Beauhurst – Cambridge outperforms London in terms of number of highgrowth tech companies per capita. Looking ahead, there are plenty of reasons to be optimistic about the future of the Cambridge Phenomenon, providing that its members can continue to draw upon the global pool of talent. The cluster continues to attract companies from around the world, as epitomised by AstraZeneca’s decision to move its global headquarters to Cambridge in May 2016. Once completed, the new £500m facility on the Cambridge Biomedical Campus will host more than 2,000 science jobs. The area also appears to be well placed to take advantage of the booming AI sector, with Samsung set to open a new AI research lab in the city that could recruit as many as 150 staff. These key facts are all the more encouraging in light of a recent UK Powerhouse report, which foresees Cambridge becoming the fastest growing economy in the UK during 2019 despite Brexit. If the area is able to capitalise on these opportunities and address its long-standing problems – such as increasing traffic congestion and spiralling house prices – we will likely hear more success stories about Silicon Fen. Legend shows minimum size of bubble. Bubbles within each legend class increase in size department upon number of employees up to the size of the next class. Source: Andy Cosh, University of Cambridge 2018. Contains Ordnance Survey data. © Crown Copyright and database right 2018. Mapping: Steve Denman, University of Cambridge.

2016-17

number of employees companies

research institutes 1-25

1-25

25-50

50-250

250+

| training and education |

| BIOSCIENCE TODAY |

The benefits of government apprenticeship reforms to employers Apprenticeships offer employers large and small a fantastic opportunity to get the skilled workforce they need to grow their business. There are hundreds of thousands of employers up and down the country that are already seeing the positive impact and energy that apprentices are bringing to their workplace. From large multinational companies like Royal Mail and Coca Cola to public sector organisations like the NHS and the Armed forces and much smaller local firms, all types of employer are offering people of all ages and backgrounds the chance to secure a great job and get ahead in their career. To help with this we’ve taken a number of steps to ensure that apprentices are gaining the skills that employers are rightly demanding. Most importantly, we have put quality at the heart of apprenticeships. We have completely overhauled the system, working closely with employers and industry to design high quality, more flexible apprenticeships known as ‘standards’. In addition, we require apprentices to spend at least 20% of their time in off the job training, and making sure through the introduction of the end point assessment in standards – delivered by an organisation specialising in these end of apprenticeship tests – apprentices are ‘job ready’. There are already over 350 new standards available in sectors from banking to hairdressing, aerospace engineering to architecture. And there are many more being developed by employers across the country in all sectors and occupations where they want to create an apprenticeship route. To ensure that quality remains consistent, we’re phasing out the old style apprenticeships known as

“Businesses can now also transfer up to 10% – increasing to 25% from April 2019 – of their levy funds to any other employer so they can benefit too.”

‘Frameworks’ so that from the start of the 2020/21 academic year, all new apprenticeship starts will be on our new standards. These changes are making sure that today’s apprenticeships reflect what businesses want and need. We also want employers to be confident that the training their apprentices are receiving is high quality. To support this we have taken decisive action to strengthen the high bar that training providers must already meet before they can register with us. Only training providers that meet the tougher registration requirements can deliver apprenticeship training and access government funding. In April 2017 we introduced the apprenticeship levy to create long-term, sustainable investment in apprenticeship training. All large firms with a pay bill of over £3 million pay the Levy and then they use it to pay for apprenticeship training of their choice. By 2019-20 we will be investing £2.45 billion in the programme annually which means more money is available than ever before for firms to invest in the next generation of workers’ training and skills, with every penny spent on apprenticeships training. Businesses can now also transfer up to 10% – increasing to 25% from April 2019 – of their levy funds to any other employer so they can benefit too. And to support smaller employers who don’t pay the Levy, but may be thinking of taking on an apprentice, we recently announced up to £240 million of additional funds to halve their apprenticeship training costs, by reducing the amount of money that they have to pay from 10% to 5%. There’s so many great reasons to hire an apprentice. They are a great way to reenergise your workplace, and bring in the skills your business needs to thrive. Everyone benefits from the economic gain of having a more skilled workforce, which is why we want to continue to encourage all employers – large and small – to take advantage of the changes we have made and consider taking on apprentices. So if you are thinking of taking the plunge and need some help the National Apprenticeships Services is on hand to offer advice and support. I can assure you won’t regret it.

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| training and education |

| BIOSCIENCE TODAY |

‘Snobbery’ is depriving people of a great career

Education Secretary hails an apprenticeship programme that is coming of age with top firms having woken up to the benefits apprentices are bringing to their workplaces

With new, higher quality apprenticeships helping people earn, learn and kick start their careers, a new campaign is launched to change perceptions of apprenticeships among young people and parents

Action to ensure young people know all of the options open to them

Leading employers have woken up to the benefits apprenticeships bring to their workplaces, Education Secretary Damian Hinds said, with top firms including Marks & Spencer and Lloyds Banking Group taking on thousands of apprentices on the Government’s new, higher quality apprenticeship programmes. At a time when many young people will be considering their futures, the Education Secretary wants parents, schools and colleges to make sure apprenticeships are being promoted alongside more traditional academic routes. The Government is launching a new campaign to promote apprenticeships among young people, parents and employers, whilst confirming that it will write to the largest school trusts who have not published information on their website about how they will ensure providers of vocational education are able talk to pupils in their schools. As the Prime Minister said in PMQs, it is important that young people are able to see that there are different routes for them for their futures, different routes into the workplace – and apprenticeships are an important route for some young people. The Government is also writing to local authorities to remind schools about the requirement to do this to make sure pupils have the full range of information about different career paths that are open to them.

Up’ campaign will aim to shift deeply held views and drive more people towards an apprenticeship. “At the same time we need to make sure that young people have access to information about all of the opportunities that are out there so we are taking action to make sure all schools invite a wide range of providers in to help young people choose the right career path for them.” Anyone considering an apprenticeship can be reassured that it offers high-quality training and a range of exciting career options. The new apprenticeships known as ‘standards’ have been developed in collaboration with leading firms to ensure they provide people with the skills and knowledge that they are looking for in job hunters. There is a huge range of apprenticeships to choose from including aerospace engineering, nuclear science, teaching, nursing, digital marketing, fashion and law, with the opportunity to study right up to degree level. Apprentices will earn while they learn and can expect to receive around 700 training hours on average – up from 560 hours the year before. The Department for Education has launched its new ‘Fire it Up’ campaign to help raise awareness of the huge variety of apprenticeship options available for people of all ages and backgrounds.

Education Secretary Damian Hinds said: “We are seeing the apprenticeship system in this country come of age, with leading employers waking up to the benefits apprenticeships can bring.

The new campaign includes national TV and social media adverts, and a new website that provides helpful advice and information as well as access to thousands of apprenticeship opportunities across the country.

“The sad truth is that outdated and snobby attitudes are still putting people off apprenticeships which means they’re missing out on great jobs and higher salaries – many of them in the sorts of firms graduates look to land jobs with after university.

To make sure young people can hear about and understand all the options available to them, like doing an apprenticeship or going to a further education college, the Government backed the Baker Clause in January 2017. The clause stipulates schools must invite a wide range of education and training providers in to help young people choose the right career path for them. Apprenticeships and Skills Minister Anne Milton is writing to the 10 largest Multi

“It’s vital that we challenge people’s thinking about apprenticeships which is why the Government’s new ‘Fire It

“we need to make sure that young people have access to information about all of the opportunities that are out there so we are taking action to make sure all schools invite a wide range of providers in to help young people choose the right career path for them.” 48

NEARLY THREE QUARTERS (71%) OF APPRENTICES AGREED THAT THEIR CHANCES OF EARNING A HIGHER WAGE IN FUTURE HAD INCREASED.

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| training and education |

Academy Trusts currently not complying with the clause to remind them of their legal duty and if there is evidence that a school is not providing their students with a full range of information, the Government will take appropriate action. Through its nationwide Enterprise Adviser Network, The Careers & Enterprise Company is also working with schools and colleges to promote technical options and apprenticeships as well giving young people more experience of the world of work.

Alim Jalloh, apprentice at Channel 4 and campaign star said: “Young people like me are thinking about their options. University is a good idea, but it is not for everyone. Ultimately it wasn’t for me because I didn’t feel it was preparing me for the job I really wanted. My apprenticeship was an amazing combination of world-class on-the-job learning, hyper relevant qualifications, with a clear potential career ahead of me. All while earning a salary!”

Analysis has highlighted the positive benefits apprenticeships are bringing to individuals and workplaces across the country, dispelling the myth that a traditional academic route is the only path to a good job. Findings include:

The Government is already taking action to transform technical and vocational education in this country. This includes working with employers to overhaul the apprenticeship system so that it delivers higher quality, more flexible apprenticeships that cover a wider range of sectors and professions and introducing new, gold standard T Levels from 2020 – the technical equivalent to A Levels.

Nearly three quarters (71%) of apprentices agreed that their chances of earning a higher wage in future had increased, and (80%) agreed that their chances of going on to higher levels of training had also increased.

In December last year, Mr Hinds set out his 10 year ambition to get more people into skilled jobs that command higher wages and help put Britain’s technical education system on a par with the best in the world. This includes:

Of those who completed an apprenticeship, 90% secured a job or went on to further learning, with 88% in sustained employment Employers also report benefits such as improved productivity (78%), improved product or service quality (74%) as well as the new ideas apprentices bring to their organisation (65%). 83% would also recommend apprentices to other business. According to a recent survey by the Sutton Trust, more and more young people are considering apprenticeships as an option after leaving school – almost two thirds (64%) said they would be interested in starting an apprenticeship instead of going to university. This is a rise of nine percentage points from 2014, when 55% of young people said they were interested in this route. The Sutton Trust survey also shows that men who start an apprenticeship earn 23% more than those who left school with only GCSEs and roughly 16% more than those who left education with a level 2 vocational qualification. For women, those who start an apprenticeship earn 15% more than those who left school with only GCSEs and about 4% more than those who left education with a level 2 vocational qualification. Mr Hinds has pointed to these figures as proof that employers and young people are starting to recognise the benefits of apprenticeships to young people and businesses.

A new generation of Higher Technical Qualifications – an alternative to a university degree to help more people get on in their careers and so employers can access the skills they need. These qualifications at ‘Level 4 and 5’ – like Diplomas of Higher Education and Foundation Degrees – sit in between A Levels and a degree in subjects like engineering and digital. The kind of training that helps someone step up from being a healthcare support worker to a nursing associate or a bricklayer to a construction site supervisor. Reforming the pupil destination measure – the information published in school and college performance tables about what higher study or training pupils go on to do after they leave – to create one measure that shows how many young people are doing higher training of any type. The new destination measure will show separately how many young people go on to study degrees, higher technical apprenticeships or Higher Technical Qualifications like a Higher National Diploma. Matching skills to jobs – new guidance and a package of support for Skills Advisory Panels – local partnerships between public and private sector employers, local authorities, colleges and universities – to assess what skills are needed in their local area.

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I really believe apprenticeships are the way forward for our career The University of Salford is recognised for links with industry, companies and corporations, both regionally, nationally and internationally. Being one of the first UK institutions to offer ‘sandwich’ courses, the university has forged strong relationships with industry over several years, creating courses that enable students to take on the challenges of today’s working world. A key part of the university’s approach to industry collaboration is the development of a number of degree apprenticeship programmes in response to growing demand from industry partners. In response to local and national skills needs and engagement with industry partners, the university has grown their apprenticeship offer from two programmes in 2016 to over ten programmes currently running and more in development for 2019/20. The university’s Environment and Life Science programmes are a key area for degree apprenticeship development. Currently running a successful Biomedical Science degree apprenticeship programme, the university has plans to develop further programmes in this area, including our BSc (Hons) Chemistry (Lab Scientist) degree apprenticeship, from September 2019 based on employer demand. The university works closely with employer partners to offer these industry-relevant programmes and is always keen to hear from employers in terms of their workforce development needs.

DEBORAH SEDDON, HAEMATOLOGY AND BLOOD BANK MANAGER, SALFORD ROYAL NHS FOUNDATION TRUST “We are currently supporting an employee through the BSc (Hons) Biomedical Science apprenticeship programme at the University of Salford. The initial interest within the NHS in apprenticeships came from the impact the levy was having on our budget. I really believe apprenticeships are the way forward for your career – being able to grow your own talent and nurture the

individual along the way results in a more knowledgeable Biomedical Scientist at the end. The apprentice will have the opportunity to encounter more situations with support before they start working alone. I also believe it is healthy to have employees on such training programmes in the department as it keeps everyone on their toes – we are all continually refreshing our knowledge of developments in the field. I am passionate about Salford and about increasing the opportunities for individuals across the region and apprenticeships are the perfect route for people to pursue a career across a number of different sectors.”

BETHANY CARR, APPRENTICE BIOMEDICAL SCIENTIST, SALFORD ROYAL NHS FOUNDATION TRUST “I am able to complete a degree when in any other circumstances I wouldn’t be able to – like most people I have rent, bills etc. which means I could never have left work to go to university – this gives me the opportunity to continue with work and get paid whilst getting my degree. I spend four days at work, and one day at university – usually this is half a day in a lab and half a day dedicated to my online lectures and independent study. This translates to 20% of my time dedicated to university each week. The experience I am getting is the most rewarding aspect of my apprenticeship. Being a biomedical scientist is such a practical based job underpinned by your theoretical knowledge – I think they are both equally important. Once I have graduated, I will qualify as a Biomedical Scientist with over 6 years’ experience (including my previous experience in the role). It is really rewarding knowing I’ve been able to achieve my goal of going to university when in other circumstances it would never have been an option for me.” Applications are now open for September 2019! Get in touch now to find out more: apprenticeships@salford.ac.uk 0161 295 4612

CAN YOU

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NOT TO? INVEST TO EMPOWER YOUR WORKFORCE A great way to attract and retain talent for your organisation, boost productivity and up-skill your workforce. Our Healthcare Science Practitioner Degree Apprenticeship allows students to exit with a full BSc (Hons) Biomedical Science degree qualification. / Apprenticeship funding available / Delivered on a part-time, day-release basis / Increase retention by offering your workforce the chance to develop and progress / Tailor apprenticesâ&#x20AC;&#x2122; learning to your requirements Get in touch today to find out more: www.salford.ac.uk/apprenticeships apprenticeships@salford.ac.uk

DEGREE APPRENTICESHIPS

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Degree apprenticeships: a first class route to building a talent pipeline Alex Felthouse Managing Director of Eisai Manufacturing Ltd and Science Industry Partnership Board Member

Degree Apprenticeships (L5- L8) provide the solution to this continuum and are set to revolutionise learning for our life sciences sector, offering a robust education pathway through to a Masters-level qualification.

Research1 undertaken in support of the Science Industry Partnership (SIP) 2025 Skills Strategy identified that the Medicines Manufacturing Sector, a strategic UK industry in which Eisai is a key player, needs to recruit around 1000 people a year, with a significant focus on highly specialist scientific roles.

These higher level apprenticeships offer an employerdesigned, structured learning programme for new entrants and existing employees. They reflect the rapidly advancing knowledge base and the increasing role of digital our sector needs to embrace in order to compete internationally. And of course they also support the sector to progress, develop and deliver solutions to our complex healthcare needs.

And indeed the wider STEM using sector will need to fill 250,000 jobs by 2025. This forecast includes up to 142,000 professional graduate level jobs and up to 73,000 technical level entry roles.

A growing number of science industry employers are now looking at how they might use their Apprenticeship Levy to fund such high quality programmes, which have been designed to not only equip the learner with key technical and scientific skills, but also the knowledge and behaviours required to work in both small and large life science organisations.

The SIP is now focussed on a skills demand and workforce planning Strategy that will take us through to 2030 – updating its research, while at the same time developing an action plan for skills, based on a gap analysis of key skills and education provision required to future proof the life science sector. In essence the skilled people required by the sector will need to come directly from education or from other related sectors. And structured, high quality training will be essential in achieving this goal. The onus is on the life sciences industry to attract people into the sector, recognising that the workforce is far more mobile than in previous years, and only by working together will we achieve this goal. With the advent of high quality L2 to L4 apprentice training in the life science sector, from research through to manufacturing, there needs to be a continuum of training to support these early entrants into industry, thus enabling them to continue their professional development and career progression.

Indeed, against a backdrop of apprenticeship uptake decline, starts in science occupations are rising, bucking the national trend - with the most recent data at 3,650 (covering Oct ‘17 to Sep ’18). This is the highest this has been since the SIP has started reporting data and the 4th consecutive 4-quarter increase (see below).

THERE ARE A RANGE OF ADVANTAGES OFFERED BY DEGREE APPRENTICESHIP ROUTES, AND ENSURING A SUCCESSFUL PROGRAMME MEANS THINKING ABOUT SKILLS REQUIREMENTS FROM THE OUTSET. Take, for example, the Laboratory Scientist Degree Apprenticeship Standard, the first one at Degree level to be developed by the SIP facilitated employer-led Life Sciences and Industrial Science (LSIS) Trailblazer Group. The latest data from the Department of Education (DfE) shows that there were 70 starts on this Standard in the first quarter of the 2018/19 academic year (Aug-Oct ’18), which is a promising take-up by the sector. It means that young people embarking on a career in our sector can achieve a full University honours degree while earning a salary, working on practical tasks in a laboratory environment. Science-using companies are utilising it as a way of developing scientific talent; undertaking this Standard can lead to a job in a range of areas and roles including Analytical Chemist, Research & Development Scientist, Molecular Biologist, Formulation Scientist, Medicinal Chemist and Process Scientist. This Apprenticeship Standard is recognised by the Science Council at Registered Scientist (RSci) level and its duration is typically 60 months.

THE WIDER STEM USING SECTOR WILL NEED TO FILL 250,000 JOBS BY 2025

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Another, more recently launched Apprenticeship Standard is Bioinformatics Scientist (Masters Degree Level) which will meet a growing need. Bioinformaticians are scientists who use computer and data mining techniques which are applied to a range of problems in the life sciences, for example, in pharmaceutical companies in the process of drug discovery and development. Roles require scientists who understand life sciences, and who can work computationally with diverse and large volumes of data derived from different life science activities.

then looks to support the development of an Apprenticeship Standard for the occupation.

When developing a new Standard, the employer-led Life Science and Industrial Science (LSIS) Trailblazer considers where such a need exists in consultation with industry, it

For Life Sciences organisations the appeal is the practical, work-based learning that takes place during the programme. Learners can apply both their knowledge and

With this in place it can work with Universities to ensure a fit-for-purpose offer in any new area. An extra part of this is then to work with the professional bodies who accredit degree programmes, to adapt such accreditations to Degree-level Apprenticeships so that apprentices and employers have equivalent measures of quality assurance and routes towards recognised professional registration.

â&#x20AC;&#x153;In essence the skilled people required by the sector will need to come directly from education or from other related sectors.â&#x20AC;? 53

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workplace experiences as part of their learning, giving them the opportunity to develop solutions to the challenges they – and their employer – are facing. A Degree Level Apprenticeship requires the apprentice to complete a work-based project and generate a “synoptic report”. This allows the apprentice to demonstrate their project management skills whilst critically evaluating their outcomes in relation to organisational needs. This supervised project essentially looks at a particular organisational challenge, chosen together with the employer. This gives the learner a deep understanding of the company and in turn provides the company with a fresh perspective. Life Science employers themselves are key to the success of such programmes, as apprentices need full and ongoing support during their study and help in applying new skills and knowledge in the work setting. It is certainly worth putting the time in to communicate the benefits of this route internally and explain the fantastic returns which can accrue from developing talent this way.

PROVISION The Science Industry Partnership recognises that finding a provider that has the right curriculum and approach and is willing to develop a deep relationship with employers, and understanding of their scientific and technical roles, is critical to the success of a Degree Apprenticeship programme. The big question right now is do we have the quality of national provision the sector requires to deliver the education we need? The work of the 2030 Skills strategy will look to assess this question by undertaking a review of vocational skills training delivery, including gap analysis of the training provision base. Producing an interactive geographical heat map of current provision and identifying where provision shortages exist.

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The UK Life Sciences sector continues to make advances in science and technology which improve all our lives, making new discoveries that deliver treatments once unimaginable. It has an ongoing need to recruit, train and develop employees and its demand for higher-level skills will only continue to intensify. This important 2030 Strategy will ensure we focus our efforts on emerging and growing skills shortages, providing us with clear priority areas that we can target with both action and solutions. It will also support us to develop a Post-Brexit skills policy to identify provision gaps that are resulting in the need to look outside of the UK for the science skills essential for growth. This approach needs to be responsive and based on employer demand, rather than the current and expedient shortage arrangements. Industry needs access to essential skills not currently available in the UK; maintaining expertise and scientific knowledge in innovation and research will be key in the future. We look forward to working with all our partners on this important work, including the Medicines Manufacturing Industry Partnership (MMIP), Association of the British Pharmaceutical Industry (ABPI), BioIndustry Association (BIA), and of course the Government Office for Life Sciences (OLS) which is leading on the Government’s Industrial Strategy for Life Sciences, for which this Strategy will deliver the key People strand of the joint industry Plan to ensure our sector is set for success. The SIP is an established, influential Employer Partnership for the science industries, which takes direct responsibility for sectoral ambition on skills. Alex Felthouse, SIP Board member, is leading on the 2030 Strategy development.

https://www.scienceindustrypartnership.com/skills-issues/skills-strategy/

www.msf.org.uk

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